ObesityBEAMNCT05713071
Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity
A study testing Bariatric Endoscopic Antral Myotomy in people with Obesity and Weight Loss, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Weight Loss, Delayed Gastric Emptying Following Procedure
- What is being tested?
- Bariatric Endoscopic Antral Myotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18-70 years of age
- Are currently in the CWMW lifestyle modification program
- Have a diagnostic endoscopy approved for bariatric evaluation
- Eligible for endoscopic and surgical weight loss procedures
- Body mass index (BMI) 30-50 kg/m2
- Individuals must be in excellent mental health
- Able to understand and sign informed consent
- Available to return for all routine follow-up study visits
Who cannot join
- Untreated H. pylori infection
- Active smoking
- Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
- Gastrointestinal obstruction
- Severe coagulopathy
Show all 21Show fewer
- Esophageal or gastric varices and/or portal hypertensive gastropathy
- Pregnancy or puerperium
- Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
- Malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
- Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
- Lactation
- History of gastrointestinal surgery
- Any serious health condition unrelated to their weight that would increase the risk of endoscopy
- Chronic abdominal pain
- Active psychological issues preventing participation in a lifestyle modification program
- A known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- An inability to provide informed consent
- Use of any medication that may interfere with weight loss
- Use of any medication that may interfere with gastric emptying
- Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin).
This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
Read the detailed description
Obesity is generally defined as a body mass index (BMI) of at least 30 kg/m2. It affects 30% of the global population and poses a significant healthcare burden. [1] Obesity has increased dramatically over the last few decades with over 650 million adults, or 13% of the world's total adult population, meeting diagnostic criteria in 2016.[1] In the U.S. the prevalence of obesity increased by 89.9% between 1993 and 2008.[1,2,3] As a result, current and potential interventions, and treatment strategies to combat obesity have become more important.
Sleeve gastrectomy, a bariatric surgical procedure, involves resection of the greater curvature of the stomach resulting in more rapid gastric emptying. It has been thought to reduce weight loss by increasing satiation as well as by triggering hindgut mechanisms. These mechanisms include increase in production of certain gut hormones, including GLP-1.[4] Sleeve gastrectomy and other bariatric surgeries are very effective at treating obesity, however, only 1% of eligible subjects elect to undergo this treatment option. Additionally, most subjects with obesity do not qualify for bariatric surgery.[5]
Endoscopic bariatric and metabolic therapies (EBMT) have recently emerged as alternative treatments for patients with obesity and a BMI over 30kg/m2. Interest in EBMT is growing given their safety, efficacy, and non-invasive nature. Current FDA- approved devices include intragastric balloons (IGB) and suturing devices for endoscopic sleeve gastroplasty (ESG). These gastric interventions work by interfering with gastric accommodation, breakdown and mixing of food, or the antral pump. All of which ultimately impact gastric emptying. IGB are space occupying devices that cause early satiation and must be removed after approximately six months, with subsequent weight regain being an issue. ESG involves endoscopic suturing to reduce the length and width of the stomach to similarly trigger earlier satiation. Delay of gastric emptying has been shown to be a major mechanism of action for both ESG and IGB, and this is also correlated with weight loss, although it is less consistent and well characterized following ESG. [6]
ESG is associated with approximately 16% TWL at one year and is well tolerated with a 1-2% SAE rate.[7] However, there are several limitations to the procedure in its current form. It is technically demanding with a long learning curve of approximately 50 cases, resulting in few centers offering the procedure, and suture loss is common raising questions of long-term durability.[8] There are also numerous suture patterns employed in clinical practice impacting the consistency of results and available suturing platforms are expensive limiting health equity.
The TransPyloric Shuttle (TPS) is a specialized balloon that resides in the gastric antrum and is the only device that incapacitates the antral pump directly impacting gastric emptying. As with other IGB, the TPS must be removed after several months resulting in subsequent weight regain.[9]
Gastroplasty with Endoscopic Myotomy (GEM) involves an abbreviated ESG of the gastric body with a pylorus-sparing antral myotomy, adding the TPS mechanism to that of traditional ESG. This employs a modification of the Gastric Peroral Endoscopic Myotomy (G-POEM) technique, targeting the antrum and leaving the pyloric ring intact to slow emptying, instead of making it more rapid. The goal of this procedure is to address the major limitations of ESG, including the procedural variability, technical difficulty, and durability. A small study has shown a consistent delay in gastric emptying with GEM, with the T ½ going from approximately 90 minutes to over 200 minutes, with 20% TWL that continues to trend downward at 6 months. Additionally, there were no new symptoms detected on the Gastroparesis Cardinal Symptom Index (GCSI) score following the procedure.
Although early results suggest the addition of antral myotomy to ESG in the GEM procedure appears to increase weight loss and consistency of delayed gastric emptying, there have been no clinical studies that investigate the efficacy of pylorus sparing antral myotomy alone, without concomitant ESG. However, this approach could have many benefits due to its less invasive nature and relative technical simplicity. There are more endoscopists with the skillset necessary to perform antral myotomy than can perform ESG, and the learning curve would also be substantially shorter. Additionally, the cost of this approach would be considerably lower than current therapies as it only involves an endoscopic procedure, an electrosurgical knife and clips for closure, with no need for an expensive suturing system.
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant ESG, on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin).
This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
- Conditions
- Obesity, Weight Loss, Delayed Gastric Emptying Following Procedure, Obesity, Mild, Obesity, Morbid, Obesity; Excess Calories
- Being tested
- Bariatric Endoscopic Antral Myotomy
- Keywords
- Bariatric Endoscopic Antral Myotomy (BEAM), Gastric physiology, Gastric emptying, Pylorus-sparing antral myotomy, Myotomy, Endoscopic Sleeve Gastroplasty (ESG), TransPyloric Shuttle (TPS), Intragastric balloon (IGB), Endoscopic bariatric and metabolic therapies (EBMT), Gut Hormones, Gastric Emptying Breath Test
- Medical subject headings
- Obesity, Weight Loss, Lymphoma, Follicular, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Endoscopic Antral MyotomyProcedure or surgery
Also called BEAM
BEAM will be performed using a standard gastric peroral endoscopic myotomy (G-POEM) technique, however with the myotomy targeting only the antrum and leaving the pyloric ring intact. G-POEM is commonly and widely employed for gastric emptying and nutritional issues and is covered by most insurance plans. This involves injecting fluid into the submucosal space, making a mucosal incision to enter the submucosal space, and tunneling along the antrum to the pylorus. A myotomy is then performed, however, in BEAM the pyloric ring is spared and the myotomy is only performed in the antrum. The incision is then closed with clips. No endoscopic suturing will be performed.
| Study group | Role | What they receive |
|---|---|---|
| BEAM Treatment Patients | Experimental | Subjects having esophagogastroduodenoscopy (EGD) with Bariatric Endoscopic Antral Myotomy (BEAM) with standard of care lifestyle modification therapy. Receives: Procedure: Bariatric Endoscopic Antral Myotomy |
| Lifestyle Modification Control Group | No intervention | Standard of care lifestyle modification therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change compared to baseline
percent total body weight loss
Measured: Screening, Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
Adverse Events
Changes to health compared to baseline
Measured: Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
Changed in pain scale from Day 0 to 12 months
How the subjects feel after the procedure based on pain scale (no pain = 1- worst possible pain = 10)
Measured: Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
Secondary outcomes (9)
Change in Quality of Life compared to baseline using the Impact of Weight on Quality of Life Lite (IWQOL-Lite) Questionnaire
Overall quality of life questionnaire (IWQOL-Lite) - scale 1 (Never True) - 5 (Always True)
Measured: Screening, 1 month, 3 month, 6 month, 9 month, 12 months
Gastric Emptying compared to baseline
Gastric emptying using a gastric emptying breath test (GEBT)
Measured: Screening, 6 months, 12 months
Ghrelin levels compared to baseline
Laboratory analysis of blood samples to test ghrelin levels
Measured: Screening, 6 months, 12 months
Change in insulin metabolic profiles compared to baseline
Laboratory analysis of insulin blood samples to test metabolic profiles
Measured: Screening, 6 months, 12 months
Change in HgA1c levels compared to baseline
Laboratory analysis of HgA1c blood samples to test metabolic profiles
Measured: Screening, 6 months, 12 months
Change in glucose levels compared to baseline
Laboratory analysis of glucose blood samples to test metabolic profiles
Measured: Screening, 6 months, 12 months
Change in HOMA-IR levels compared to baseline
Laboratory analysis of HOMA-IR blood samples to test insulin resistance
Measured: Screening, 6 months, 12 months
Radiological (Upper GI Series) gastric emptying rate (minutes) of barium transit from esophagus through stomach to small intestine compared to baseline
Upper GI series comparing barium transit from baseline to 6 and 12 months post-procedure.
Measured: Screening, 6 months, 12 months
Radiological (Dynamic MRI) gastric emptying rate (minutes) of contrast transit from esophagus, through stomach to small intestine compared to baseline compared to baseline
Dynamic MRI comparing contrast transit from baseline to 1 month post-procedure.
Measured: Screening, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start21 Feb 2024
- Primary completion26 Jun 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology compared to lifestyle modification therapy alone. At 6 months control group will crossover to treatment group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Principal investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713071
- Sponsor's protocol ID
- 2022P003399
- Acronym
- BEAM
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study for potential NIH Grant submission, we do not plan to share data with other researchers at this time.
Publications
Klem ML, Wing RR, Chang CC, Lang W, McGuire MT, Sugerman HJ, Hutchison SL, Makovich AL, Hill JO. A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means. Int J Obes Relat Metab Disord. 2000 May;24(5):573-9. doi: 10.1038/sj.ijo.0801199.
PubMed 10849578James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
PubMed 11707546Jia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026.
PubMed 20709253McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
PubMed 31592891Abu 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 23711556Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.
PubMed 27465076Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.
PubMed 31442601Saumoy M, Schneider Y, Zhou XK, Shukla A, Kahaleh M, Aronne L, Sharaiha RZ. A single-operator learning curve analysis for the endoscopic sleeve gastroplasty. Gastrointest Endosc. 2018 Feb;87(2):442-447. doi: 10.1016/j.gie.2017.08.014. Epub 2017 Aug 24.
PubMed 28843586Marinos G, Eliades C, Raman Muthusamy V, Greenway F. Weight loss and improved quality of life with a nonsurgical endoscopic treatment for obesity: clinical results from a 3- and 6-month study. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):929-34. doi: 10.1016/j.soard.2014.03.005. Epub 2014 Mar 12.
PubMed 25066439Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.
PubMed 30842971Mohan BP, Chandan S, Jha LK, Khan SR, Kotagiri R, Kassab LL, Ravikumar NPG, Bhogal N, Chandan OC, Bhat I, Hewlett AT, Jacques J, Ponnada S, Asokkumar R, Adler DG. Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Surg Endosc. 2020 Aug;34(8):3352-3367. doi: 10.1007/s00464-019-07135-9. Epub 2019 Oct 3.
PubMed 31583465
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity
- ClinicalTrials.gov ID
- NCT05713071
- Acronym / sponsor ID
- BEAM / 2022P003399
- Conditions
- Obesity, Weight Loss, Delayed Gastric Emptying Following Procedure, Obesity, Mild, Obesity, Morbid, Obesity; Excess Calories
- Keywords
- Bariatric Endoscopic Antral Myotomy (BEAM), Gastric physiology, Gastric emptying, Pylorus-sparing antral myotomy, Myotomy, Endoscopic Sleeve Gastroplasty (ESG), TransPyloric Shuttle (TPS), Intragastric balloon (IGB)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2023 (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.
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin).
This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
Detailed description
Obesity is generally defined as a body mass index (BMI) of at least 30 kg/m2. It affects 30% of the global population and poses a significant healthcare burden. [1] Obesity has increased dramatically over the last few decades with over 650 million adults, or 13% of the world's total adult population, meeting diagnostic criteria in 2016.[1] In the U.S. the prevalence of obesity increased by 89.9% between 1993 and 2008.[1,2,3] As a result, current and potential interventions, and treatment strategies to combat obesity have become more important.
Sleeve gastrectomy, a bariatric surgical procedure, involves resection of the greater curvature of the stomach resulting in more rapid gastric emptying. It has been thought to reduce weight loss by increasing satiation as well as by triggering hindgut mechanisms. These mechanisms include increase in production of certain gut hormones, including GLP-1.[4] Sleeve gastrectomy and other bariatric surgeries are very effective at treating obesity, however, only 1% of eligible subjects elect to undergo this treatment option. Additionally, most subjects with obesity do not qualify for bariatric surgery.[5]
Endoscopic bariatric and metabolic therapies (EBMT) have recently emerged as alternative treatments for patients with obesity and a BMI over 30kg/m2. Interest in EBMT is growing given their safety, efficacy, and non-invasive nature. Current FDA- approved devices include intragastric balloons (IGB) and suturing devices for endoscopic sleeve gastroplasty (ESG). These gastric interventions work by interfering with gastric accommodation, breakdown and mixing of food, or the antral pump. All of which ultimately impact gastric emptying. IGB are space occupying devices that cause early satiation and must be removed after approximately six months, with subsequent weight regain being an issue. ESG involves endoscopic suturing to reduce the length and width of the stomach to similarly trigger earlier satiation. Delay of gastric emptying has been shown to be a major mechanism of action for both ESG and IGB, and this is also correlated with weight loss, although it is less consistent and well characterized following ESG. [6]
ESG is associated with approximately 16% TWL at one year and is well tolerated with a 1-2% SAE rate.[7] However, there are several limitations to the procedure in its current form. It is technically demanding with a long learning curve of approximately 50 cases, resulting in few centers offering the procedure, and suture loss is common raising questions of long-term durability.[8] There are also numerous suture patterns employed in clinical practice impacting the consistency of results and available suturing platforms are expensive limiting health equity.
The TransPyloric Shuttle (TPS) is a specialized balloon that resides in the gastric antrum and is the only device that incapacitates the antral pump directly impacting gastric emptying. As with other IGB, the TPS must be removed after several months resulting in subsequent weight regain.[9]
Gastroplasty with Endoscopic Myotomy (GEM) involves an abbreviated ESG of the gastric body with a pylorus-sparing antral myotomy, adding the TPS mechanism to that of traditional ESG. This employs a modification of the Gastric Peroral Endoscopic Myotomy (G-POEM) technique, targeting the antrum and leaving the pyloric ring intact to slow emptying, instead of making it more rapid. The goal of this procedure is to address the major limitations of ESG, including the procedural variability, technical difficulty, and durability. A small study has shown a consistent delay in gastric emptying with GEM, with the T ½ going from approximately 90 minutes to over 200 minutes, with 20% TWL that continues to trend downward at 6 months. Additionally, there were no new symptoms detected on the Gastroparesis Cardinal Symptom Index (GCSI) score following the procedure.
Although early results suggest the addition of antral myotomy to ESG in the GEM procedure appears to increase weight loss and consistency of delayed gastric emptying, there have been no clinical studies that investigate the efficacy of pylorus sparing antral myotomy alone, without concomitant ESG. However, this approach could have many benefits due to its less invasive nature and relative technical simplicity. There are more endoscopists with the skillset necessary to perform antral myotomy than can perform ESG, and the learning curve would also be substantially shorter. Additionally, the cost of this approach would be considerably lower than current therapies as it only involves an endoscopic procedure, an electrosurgical knife and clips for closure, with no need for an expensive suturing system.
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant ESG, on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin).
This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology compared to lifestyle modification therapy alone. At 6 months control group will crossover to treatment group.
| Arm | Type | Receives |
|---|---|---|
| BEAM Treatment Patients | Experimental | Procedure: Bariatric Endoscopic Antral MyotomySubjects having esophagogastroduodenoscopy (EGD) with Bariatric Endoscopic Antral Myotomy (BEAM) with standard of care lifestyle modification therapy. |
| Lifestyle Modification Control Group | No intervention | –Standard of care lifestyle modification therapy only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be 18-70 years of age
- Are currently in the CWMW lifestyle modification program
- Have a diagnostic endoscopy approved for bariatric evaluation
- Eligible for endoscopic and surgical weight loss procedures
- Body mass index (BMI) 30-50 kg/m2
Key exclusion criteria (21 listed)
- Untreated H. pylori infection
- Active smoking
- Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
- Previous pyloromyotomy or pyloroplasty
- Gastrointestinal obstruction
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 |
|---|---|---|
| Bariatric Endoscopic Antral MyotomyAlso: BEAMBEAM will be performed using a standard gastric peroral endoscopic myotomy (G-POEM) technique, however with the myotomy targeting only the antrum and leaving the pyloric ring intact. G-POEM is commonly and widely employed for gastric emptying and nutritional issues and is covered by most insurance plans. This involves injecting fluid into the submucosal space, making a mucosal incision to enter the submucosal space, and tunneling along the antrum to the pylorus. A myotomy is then performed, however, in BEAM the pyloric ring is spared and the myotomy is only performed in the antrum. The incision is then closed with clips. No endoscopic suturing will be performed. | Procedure or surgery | BEAM Treatment Patients |
Primary outcome
Weight change compared to baseline
Time frame: Screening, Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
percent total body weight loss
Adverse Events
Time frame: Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
Changes to health compared to baseline
Changed in pain scale from Day 0 to 12 months
Time frame: Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months
How the subjects feel after the procedure based on pain scale (no pain = 1- worst possible pain = 10)
9 secondary outcomes
Change in Quality of Life compared to baseline using the Impact of Weight on Quality of Life Lite (IWQOL-Lite) Questionnaire
Time frame: Screening, 1 month, 3 month, 6 month, 9 month, 12 months
Gastric Emptying compared to baseline
Time frame: Screening, 6 months, 12 months
Ghrelin levels compared to baseline
Time frame: Screening, 6 months, 12 months
Change in insulin metabolic profiles compared to baseline
Time frame: Screening, 6 months, 12 months
Change in HgA1c levels compared to baseline
Time frame: Screening, 6 months, 12 months
Change in glucose levels compared to baseline
Time frame: Screening, 6 months, 12 months
Change in HOMA-IR levels compared to baseline
Time frame: Screening, 6 months, 12 months
Radiological (Upper GI Series) gastric emptying rate (minutes) of barium transit from esophagus through stomach to small intestine compared to baseline
Time frame: Screening, 6 months, 12 months
Radiological (Dynamic MRI) gastric emptying rate (minutes) of contrast transit from esophagus, through stomach to small intestine compared to baseline compared to baseline
Time frame: Screening, 1 month
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 25 Jun 2026.
- Background: PubMed 10849578Klem ML, Wing RR, Chang CC, Lang W, McGuire MT, Sugerman HJ, Hutchison SL, Makovich AL, Hill JO. A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means. Int J Obes Relat Metab Disord. 2000 May;24(5):573-9. doi: 10.1038/sj.ijo.0801199.
- Background: PubMed 11707546James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
- Background: PubMed 20709253Jia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026.
- Background: PubMed 31592891McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
- 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.
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- Individual participant dataSharing planned: No. As this is a pilot study for potential NIH Grant submission, we do not plan to share data with other researchers at this time.
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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. This study is not recruiting at the moment.
Christopher C. Thompson, MD, MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Endoscopic Antral Myotomy in people with Obesity and Weight Loss, run by Brigham and Women's Hospital 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 8 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change compared to baseline (time frame: Screening, Day 0/Treatment, 1 month, 3 month, 6 month, 9 month, 12 months). The study lists 3 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 NCT05713071, which also lists 11 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 25 Jun 2026.