ObesityNCT07792226
ENLIGHT Trial: ESG With Fundal Mucosal Ablation
A study testing Endoscopic Sleeve Gastroplasty (ESG) and Fundal Mucosal Ablation in people with Obesity and Obesity (Body Mass Index >30 kg/m2), run by West Virginia University at 1 site in United States.
Trial summary
The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Endoscopic Sleeve Gastroplasty (ESG) and Fundal Mucosal Ablation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years
- Subjects with a BMI ≥30 kg/m²
- Subjects have a history of failure of at least one prior weight loss attempt, including but not limited to dietary modification, physical exercise, behavioral modification, pharmacologic therapy (alone or in combination), or other non-surgical weight reduction methods.
- Willing and able to comply with all study requirements, including but not limited to signing a written informed consent form prior to participation, routine follow-up visit schedule, completing all required laboratory, imaging, and additional assessments, and participating in dietary counseling sessions.
- Women of childbearing potential (i.e., not postmenopausal and not surgically sterilized) must agree to use adequate and effective contraception methods throughout the study period.
- Able to travel to visit the study site and have access to the internet to facilitate remote follow-up activities, as applicable.
Who cannot join
- Prior gastric or bariatric surgery/procedure that may affect the anatomy or feasibility of the intervention, (e.g; prior Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty).
- Clinically significant structural abnormality that may increase procedural risk or interfere with endoscopic access
- Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
- Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
- Pregnancy, breastfeeding, or any other condition that, in the opinion of the investigator or treating physician, would make participation unsafe or interfere with study procedures.
- Other cases deemed by the examining physician as unsuitable for safe treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Zim Warda Hasan, MBBS, MS, 364-203-1900, zh00027@mix.wvu.edu
Shailendra Singh, MD, FASGE
About this study
Official title: A Single-center Randomized Controlled Trial Evaluating Whether Adding Fundal Mucosal Ablation (FMA) to Standard Endoscopic Sleeve Gastroplasty (ESG) Leads to Greater Weight Loss, Improved Obesity-related Comorbidities, and Better Metabolic and Hormonal Outcomes Compared With ESG Alone in Adults With Obesity.
The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized on the procedure day to either ESG with FMA or standard ESG alone. The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized 1:1 on the procedure day to either ESG with FMA or standard ESG alone. The primary outcome is the difference between groups in percentage total body weight loss at 12 months. Secondary outcomes include percent excess weight loss, fasting ghrelin levels, blood pressure and antihypertensive medication use, lipid profile, fasting glucose, insulin, HbA1c, insulin resistance, hepatic steatosis and fibrosis measures, quality of life, pain, gastric symptoms, appetite and eating behavior, and the frequency and severity of adverse events.
Read the detailed description
Obesity is associated with a number of chronic health conditions, including type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea, and metabolic liver disease. Treatment options include lifestyle modification, anti-obesity medications, bariatric surgery, and endoscopic weight-loss procedures.
ESG is an endoscopic procedure in which full-thickness sutures are placed to reduce the volume and length of the stomach and create a sleeve-like configuration. The gastric fundus is generally preserved during ESG. Although ESG has been shown to produce clinically meaningful weight loss, weight loss following ESG is generally less than that achieved with surgical sleeve gastrectomy.
One possible explanation for this difference is the role of the gastric fundus in appetite regulation. The fundus contains a large number of cells that produce ghrelin, a hormone involved in hunger and food intake. Procedures that remove or alter the gastric fundus may reduce circulating ghrelin levels. Fundal mucosal ablation (FMA) is an emerging endoscopic technique designed to treat the mucosal lining of the gastric fundus while preserving the stomach itself. Early studies have suggested that FMA may reduce fasting ghrelin levels and may contribute to reductions in hunger and body weight. The ENLIGHT trial is designed to determine whether adding FMA to standard ESG provides additional benefit compared with ESG alone.
Participants assigned to the ESG group will undergo standard ESG under general anesthesia. Participants assigned to the ESG with FMA group will undergo standard ESG together with FMA during the same procedure. Following the procedure, participants in both groups will receive similar standard post-procedure care. Participants will be followed for approximately 52 weeks after the procedure.
Study Significance
The ENLIGHT Trial is intended to provide comparative evidence regarding whether adding FMA to ESG improves weight loss while maintaining an acceptable safety and tolerability profile. The study will also help determine whether the combined procedure has additional effects on metabolic health, obesity-related conditions, patient-reported outcomes, and fasting ghrelin levels.
- Conditions
- Obesity, Obesity (Body Mass Index >30 kg/m2)
- Being tested
- Endoscopic Sleeve Gastroplasty (ESG), Fundal Mucosal Ablation
- Keywords
- Obesity, Diabetes Mellitus, MASH, Circulation Disorder, Diabetes Prevention, Type 2 Diabetes (Adult Onset), Vascular Disease, Liver Diseases
- Medical subject headings
- Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Vascular Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve Gastroplasty (ESG)Device
Endoscopic sleeve gastroplasty (ESG) is performed under general anesthesia using a flexible endoscope and full-thickness endoscopic suturing. Sutures are placed along the greater curvature of the stomach to create a smaller, sleeve-like gastric configuration while preserving the gastric fundus. The procedure is intended to reduce gastric volume, promote earlier satiety, and support weight loss.
Fundal Mucosal AblationProcedure or surgery
Fundal mucosal ablation is performed during the same procedural session as endoscopic sleeve gastroplasty. The gastric fundal mucosa is lifted using a submucosal injection of saline and methylene blue and then treated with controlled Hybrid Argon Plasma Coagulation. The procedure is intended to ablate superficial ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and supporting weight loss.
| Study group | Role | What they receive |
|---|---|---|
| ESG with Fundal Mucosal Ablation | Experimental | Not described Receives: Device: Endoscopic Sleeve Gastroplasty (ESG); Procedure: Fundal Mucosal Ablation |
| Endoscopic Sleeve Gastroplasty (ESG) Alone | Active comparator | Not described Receives: Device: Endoscopic Sleeve Gastroplasty (ESG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month
Measured: Baseline to 1 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month
Measured: Baseline to 3 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month
Measured: Baseline to 6 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month
Measured: Baseline to 9 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month
Measured: Baseline to 12 month
Secondary outcomes (65)
Percent change in Excess Weight Loss (%EWL) from baseline to 1 month
Measured: Baseline to 1 month
Percent change in Excess Weight Loss (%EWL) from baseline to 3 month
Measured: Baseline to 3 month
Percent change in Excess Weight Loss (%EWL) from baseline to 6 month
Measured: Baseline to 6 month
Percent change in Excess Weight Loss (%EWL) from baseline to 9 month
Measured: Baseline to 9 month
Percent change in Excess Weight Loss (%EWL) from baseline to 12 month
Measured: Baseline to 12 month
Number of Participants With Procedure-Related Adverse Events (1 Month)
Measured: Up to 1 month after procedure
Number of Participants With Procedure-Related Adverse Events (3 Month)
Measured: Up to 3 month after procedure
Number of Participants With Procedure-Related Adverse Events (6 Month)
Measured: Up to 6 month after procedure
Number of Participants With Procedure-Related Adverse Events (9 Month)
Measured: Up to 9 month after procedure
Number of Participants With Procedure-Related Adverse Events (12 Month)
Measured: Up to 12 month after procedure
Change in Plasma Ghrelin level from baseline to 1 month
Measured: Baseline to 1 month
Change in Plasma Ghrelin level from baseline to 6 month
Measured: Baseline to 6 month
Change in Plasma Ghrelin level from baseline to 12 month
Measured: Baseline to 12 month
Change in Systolic Blood Pressure from Baseline to 1 Month
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 1 month
Change in Diastolic Blood Pressure from Baseline to 1 Month
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 1 month
Change in Systolic Blood Pressure from Baseline to 3 Months
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 3 months
Change in Diastolic Blood Pressure from Baseline to 3 Months
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 3 months
Change in Systolic Blood Pressure from Baseline to 6 Months
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 6 months
Change in Diastolic Blood Pressure from Baseline to 6 Months
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 6 months
Change in Systolic Blood Pressure from Baseline to 9 Months
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 9 months
Change in Diastolic Blood Pressure from Baseline to 9 Months
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 9 months
Change in Systolic Blood Pressure from Baseline to 12 Months
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 12 months
Change in Diastolic Blood Pressure from Baseline to 12 Months
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.
Measured: Baseline to 12 months
Change in Fasting Plasma Glucose from Baseline to 1 Month
Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).
Measured: Baseline to 1 month
Change in Fasting Plasma Glucose from Baseline to 6 Months
Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 months
Change in Fasting Plasma Glucose from Baseline to 12 Months
Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).
Measured: Baseline to 12 months
Change in Fasting Serum Insulin Concentration from Baseline to 1 Month
Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).
Measured: Baseline to 1 month
Change in Fasting Serum Insulin Concentration from Baseline to 6 Months
Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).
Measured: Baseline to 6 months
Change in Fasting Serum Insulin Concentration from Baseline to 12 Months
Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).
Measured: Baseline to 12 months
Change in Hemoglobin A1c (HbA1c) from Baseline to 1 Month
HbA1c will be measured as a percentage (%) of total hemoglobin.
Measured: Baseline to 1 month
Change in Hemoglobin A1c (HbA1c) from Baseline to 6 Months
HbA1c will be measured as a percentage (%) of total hemoglobin.
Measured: Baseline to 6 months
Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months
HbA1c will be measured as a percentage (%) of total hemoglobin.
Measured: Baseline to 12 months
Change in Total Cholesterol from Baseline to 1 Month
Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 1 month
Change in Total Cholesterol from Baseline to 6 Months
Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 months
Change in Total Cholesterol from Baseline to 12 Months
Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 12 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 1 Month
Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 1 month
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 6 Months
Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 12 Months
Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 12 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 1 Month
High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 1 month
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 6 Months
High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 12 Months
High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 12 months
Change in Triglycerides from Baseline to 1 Month
Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 1 month
Change in Triglycerides from Baseline to 6 Months
Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 months
Change in Triglycerides from Baseline to 12 Months
Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).
Measured: Baseline to 12 months
Change in Hepatic Steatosis Index (HSI) from Baseline to 1 Month
HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.
Measured: Baseline to 1 month
Change in Hepatic Steatosis Index (HSI) from Baseline to 6 Months
HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.
Measured: Baseline to 6 months
Change in Hepatic Steatosis Index (HSI) from Baseline to 12 Months
HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.
Measured: Baseline to 12 months
Change in Liver Stiffness Measurement from Baseline to 1 Month
Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.
Measured: Baseline to 1 month
Change in Liver Stiffness Measurement from Baseline to 6 Months
Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.
Measured: Baseline to 6 months
Change in Liver Stiffness Measurement from Baseline to 12 Months
Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.
Measured: Baseline to 12 months
Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 1 Month
Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.
Measured: Baseline to 1 month
Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 3 Months
Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.
Measured: Baseline to 3 months
Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 6 Months
Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.
Measured: Baseline to 6 months
Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 12 Months
Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.
Measured: Baseline to 12 months
Change in plasma leptin level from baseline to 1 month
Measured: Baseline to 1 month
Change in plasma leptin level from baseline to 6 months
Measured: Baseline to 6 months
Change in plasma leptin level from baseline to 12 months
Measured: Baseline to 12 months
Change in resistance to overeating from baseline to 1 month
Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.
Measured: Baseline to 1 month
Change in resistance to overeating from baseline to 3 months
Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.
Measured: Baseline to 3 months
Change in resistance to overeating from baseline to 6 months
Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.
Measured: Baseline to 6 months
Change in resistance to overeating from baseline to 12 months
Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.
Measured: Baseline to 12 months
Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 1 month
Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.
Measured: Baseline to 1 month
Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 3 months
Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.
Measured: Baseline to 3 months
Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 6 months
Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.
Measured: Baseline to 6 months
Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 12 months
Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shailendra Singh, West Virginia University
- Investigators
- Shailendra Singh, MD, FASGE, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792226
- Sponsor's protocol ID
- STUDY00000243
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gadde KM, Atkins KD. The limits and challenges of antiobesity pharmacotherapy. Expert Opin Pharmacother. 2020 Aug;21(11):1319-1328. doi: 10.1080/14656566.2020.1748599. Epub 2020 Apr 15.
PubMed 32292094Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
PubMed 23711556Gadi SRV, Maselli DB, Donnangelo LL, Wooley C, Comer T, Casey S, Jain A, Jain A, Chapman CG, Bakheet N, Badurdeen D, Kumbhari V, McGowan CE. Gastric fundal mucosal ablation followed by endoscopic sleeve gastroplasty in adults with obesity: a first-in-human two-phase pilot clinical trial. Endoscopy. 2026 Mar 26. doi: 10.1055/a-2823-8603. Online ahead of print.
PubMed 41760139Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
PubMed 35908555Maselli DB, Donnangelo LL, Wooley C, Chapman C, Kumbhari V, Mcgowan CE. Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.e3. doi: 10.1053/j.gastro.2024.08.008. Epub 2024 Aug 21. No abstract available.
PubMed 39154777Chao AM, Paul A, Hodgkins JV, Wadden TA. A Guideline-Directed Approach to Obesity Treatment. Diabetes Spectr. 2024 Nov 15;37(4):281-295. doi: 10.2337/dsi24-0001. eCollection 2024 Fall.
PubMed 39649692
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Trial Evaluating Whether Adding Fundal Mucosal Ablation (FMA) to Standard Endoscopic Sleeve Gastroplasty (ESG) Leads to Greater Weight Loss, Improved Obesity-related Comorbidities, and Better Metabolic and Hormonal Outcomes Compared With ESG Alone in Adults With Obesity.
- ClinicalTrials.gov ID
- NCT07792226
- Acronym / sponsor ID
- STUDY00000243
- Conditions
- Obesity, Obesity (Body Mass Index >30 kg/m2)
- Keywords
- Obesity, Diabetes Mellitus, MASH, Circulation Disorder, Diabetes Prevention, Type 2 Diabetes (Adult Onset), Vascular Disease, Liver Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized on the procedure day to either ESG with FMA or standard ESG alone. The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized 1:1 on the procedure day to either ESG with FMA or standard ESG alone. The primary outcome is the difference between groups in percentage total body weight loss at 12 months. Secondary outcomes include percent excess weight loss, fasting ghrelin levels, blood pressure and antihypertensive medication use, lipid profile, fasting glucose, insulin, HbA1c, insulin resistance, hepatic steatosis and fibrosis measures, quality of life, pain, gastric symptoms, appetite and eating behavior, and the frequency and severity of adverse events.
Detailed description
Obesity is associated with a number of chronic health conditions, including type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea, and metabolic liver disease. Treatment options include lifestyle modification, anti-obesity medications, bariatric surgery, and endoscopic weight-loss procedures.
ESG is an endoscopic procedure in which full-thickness sutures are placed to reduce the volume and length of the stomach and create a sleeve-like configuration. The gastric fundus is generally preserved during ESG. Although ESG has been shown to produce clinically meaningful weight loss, weight loss following ESG is generally less than that achieved with surgical sleeve gastrectomy.
One possible explanation for this difference is the role of the gastric fundus in appetite regulation. The fundus contains a large number of cells that produce ghrelin, a hormone involved in hunger and food intake. Procedures that remove or alter the gastric fundus may reduce circulating ghrelin levels. Fundal mucosal ablation (FMA) is an emerging endoscopic technique designed to treat the mucosal lining of the gastric fundus while preserving the stomach itself. Early studies have suggested that FMA may reduce fasting ghrelin levels and may contribute to reductions in hunger and body weight. The ENLIGHT trial is designed to determine whether adding FMA to standard ESG provides additional benefit compared with ESG alone.
Participants assigned to the ESG group will undergo standard ESG under general anesthesia. Participants assigned to the ESG with FMA group will undergo standard ESG together with FMA during the same procedure. Following the procedure, participants in both groups will receive similar standard post-procedure care. Participants will be followed for approximately 52 weeks after the procedure.
Study Significance
The ENLIGHT Trial is intended to provide comparative evidence regarding whether adding FMA to ESG improves weight loss while maintaining an acceptable safety and tolerability profile. The study will also help determine whether the combined procedure has additional effects on metabolic health, obesity-related conditions, patient-reported outcomes, and fasting ghrelin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESG with Fundal Mucosal Ablation | Experimental | Device: Endoscopic Sleeve Gastroplasty (ESG), Procedure: Fundal Mucosal Ablation |
| Endoscopic Sleeve Gastroplasty (ESG) Alone | Active comparator | Device: Endoscopic Sleeve Gastroplasty (ESG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged ≥18 years
- Subjects with a BMI ≥30 kg/m²
- Subjects have a history of failure of at least one prior weight loss attempt, including but not limited to dietary modification, physical exercise, behavioral modification, pharmacologic therapy (alone or in combination), or other non-surgical weight reduction methods.
- Willing and able to comply with all study requirements, including but not limited to signing a written informed consent form prior to participation, routine follow-up visit schedule, completing all required laboratory, imaging, and additional assessments, and participating in dietary counseling sessions.
- Women of childbearing potential (i.e., not postmenopausal and not surgically sterilized) must agree to use adequate and effective contraception methods throughout the study period.
Key exclusion criteria (6 listed)
- Prior gastric or bariatric surgery/procedure that may affect the anatomy or feasibility of the intervention, (e.g; prior Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty).
- Clinically significant structural abnormality that may increase procedural risk or interfere with endoscopic access
- Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
- Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
- Pregnancy, breastfeeding, or any other condition that, in the opinion of the investigator or treating physician, would make participation unsafe or interfere with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG)Endoscopic sleeve gastroplasty (ESG) is performed under general anesthesia using a flexible endoscope and full-thickness endoscopic suturing. Sutures are placed along the greater curvature of the stomach to create a smaller, sleeve-like gastric configuration while preserving the gastric fundus. The procedure is intended to reduce gastric volume, promote earlier satiety, and support weight loss. | Device | ESG with Fundal Mucosal Ablation, Endoscopic Sleeve Gastroplasty (ESG) Alone |
| Fundal Mucosal AblationFundal mucosal ablation is performed during the same procedural session as endoscopic sleeve gastroplasty. The gastric fundal mucosa is lifted using a submucosal injection of saline and methylene blue and then treated with controlled Hybrid Argon Plasma Coagulation. The procedure is intended to ablate superficial ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and supporting weight loss. | Procedure or surgery | ESG with Fundal Mucosal Ablation |
Primary outcome
Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month
Time frame: Baseline to 1 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month
Time frame: Baseline to 3 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month
Time frame: Baseline to 6 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month
Time frame: Baseline to 9 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month
Time frame: Baseline to 12 month
65 secondary outcomes
Percent change in Excess Weight Loss (%EWL) from baseline to 1 month
Time frame: Baseline to 1 month
Percent change in Excess Weight Loss (%EWL) from baseline to 3 month
Time frame: Baseline to 3 month
Percent change in Excess Weight Loss (%EWL) from baseline to 6 month
Time frame: Baseline to 6 month
Percent change in Excess Weight Loss (%EWL) from baseline to 9 month
Time frame: Baseline to 9 month
Percent change in Excess Weight Loss (%EWL) from baseline to 12 month
Time frame: Baseline to 12 month
Number of Participants With Procedure-Related Adverse Events (1 Month)
Time frame: Up to 1 month after procedure
Number of Participants With Procedure-Related Adverse Events (3 Month)
Time frame: Up to 3 month after procedure
Number of Participants With Procedure-Related Adverse Events (6 Month)
Time frame: Up to 6 month after procedure
Number of Participants With Procedure-Related Adverse Events (9 Month)
Time frame: Up to 9 month after procedure
Number of Participants With Procedure-Related Adverse Events (12 Month)
Time frame: Up to 12 month after procedure
Change in Plasma Ghrelin level from baseline to 1 month
Time frame: Baseline to 1 month
Change in Plasma Ghrelin level from baseline to 6 month
Time frame: Baseline to 6 month
Change in Plasma Ghrelin level from baseline to 12 month
Time frame: Baseline to 12 month
Change in Systolic Blood Pressure from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Diastolic Blood Pressure from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Systolic Blood Pressure from Baseline to 3 Months
Time frame: Baseline to 3 months
Change in Diastolic Blood Pressure from Baseline to 3 Months
Time frame: Baseline to 3 months
Change in Systolic Blood Pressure from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Diastolic Blood Pressure from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Systolic Blood Pressure from Baseline to 9 Months
Time frame: Baseline to 9 months
Change in Diastolic Blood Pressure from Baseline to 9 Months
Time frame: Baseline to 9 months
Change in Systolic Blood Pressure from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Diastolic Blood Pressure from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Fasting Plasma Glucose from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Fasting Plasma Glucose from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Fasting Plasma Glucose from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Fasting Serum Insulin Concentration from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Fasting Serum Insulin Concentration from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Fasting Serum Insulin Concentration from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Hemoglobin A1c (HbA1c) from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Hemoglobin A1c (HbA1c) from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Total Cholesterol from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Total Cholesterol from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Total Cholesterol from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 6 Months
Time frame: Baseline to 6 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 12 Months
Time frame: Baseline to 12 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 1 Month
Time frame: Baseline to 1 month
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 6 Months
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 32292094Gadde KM, Atkins KD. The limits and challenges of antiobesity pharmacotherapy. Expert Opin Pharmacother. 2020 Aug;21(11):1319-1328. doi: 10.1080/14656566.2020.1748599. Epub 2020 Apr 15.
- Background: PubMed 23711556Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
- Background: PubMed 41760139Gadi SRV, Maselli DB, Donnangelo LL, Wooley C, Comer T, Casey S, Jain A, Jain A, Chapman CG, Bakheet N, Badurdeen D, Kumbhari V, McGowan CE. Gastric fundal mucosal ablation followed by endoscopic sleeve gastroplasty in adults with obesity: a first-in-human two-phase pilot clinical trial. Endoscopy. 2026 Mar 26. doi: 10.1055/a-2823-8603. Online ahead of print.
- Background: PubMed 35908555Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
- Background: PubMed 39154777Maselli DB, Donnangelo LL, Wooley C, Chapman C, Kumbhari V, Mcgowan CE. Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.e3. doi: 10.1053/j.gastro.2024.08.008. Epub 2024 Aug 21. No abstract available.
- Background: PubMed 39649692Chao AM, Paul A, Hodgkins JV, Wadden TA. A Guideline-Directed Approach to Obesity Treatment. Diabetes Spectr. 2024 Nov 15;37(4):281-295. doi: 10.2337/dsi24-0001. eCollection 2024 Fall.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shailendra Singh, MD, FASGE principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastroplasty (ESG) and Fundal Mucosal Ablation in people with Obesity and Obesity (Body Mass Index >30 kg/m2), run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zim Warda Hasan, MBBS, MS (364-203-1900, zh00027@mix.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month (time frame: Baseline to 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07792226, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.