Obese AdolescentsNCT06914765
ESG in Obese Adolescents
A study testing Endoscopic Sleeve Gastroplasty (ESG) Procedure in people with Obese Adolescents and Obesity, Morbid, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The primary goal of this pilot study is to learn if the use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in adolescents with obesity. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obese Adolescents, Obesity, Morbid, Obesity/Therapy
- What is being tested?
- Endoscopic Sleeve Gastroplasty (ESG) Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Jan 2030
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Female or male, age ≥ 12 years and ≤17 years at the time of study initiation (defined as the time of consent for participation in the pilot study).
- BMI ≥95th percentile to 120% of the 95th percentile on the Centers for Disease Control and Prevention (CDC) growth curve with at least one obesity related comorbidity; OR BMI ≥ 120% of the 95th percentile on the CDC growth curve regardless of the presence or absence of comorbidities. Clinically significant obesity related comorbidities including type 2 diabetes mellitus, idiopathic intracranial hypertension (IIH), non-alcoholic steatohepatitis (NASH) now called metabolic dysfunction-associated steatohepatitis (MASH), Blount's disease, Slipped Capital Femoral Epiphysis (SCFE), sleep apnea defined as AHI ≥ 5, Gastroesophageal Reflux Disease (GERD), hypertension, or dyslipidemia.
- Must have a documented history of weight management and weight loss attempts with supervised diets and exercise programs for at least 6 months from a Healthy Weight provider.
- All female subjects must have a negative serum pregnancy test.
- Has a signed note from a medically supervised weight loss program that the patient demonstrates commitment to nutrition, psychological, and physical activity evaluations and follow-ups in the Healthy Weight clinics, without frequent non-compliance or no-shows.
- Demonstrates ability to understand what dietary and physical activity changes will be required for optimal postoperative outcomes based on psychology assessment.
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- Evidence for mature decision making, with appropriate understanding of potential risks and benefits of the procedure as deemed by a clinical psychologist.
- No documented genetic cause for obesity or excessive weight gain such as Prader-Willi syndrome
- Evidence that family and patient have the ability and motivation to comply with recommended treatments pre- and postoperatively. Evidence may include a history of reliable attendance at office visits for weight management and compliance with other medical needs.
- Female participants must agree to avoid pregnancy for the duration of the study and acknowledge that they will be withdrawn from the study if they do become pregnant.
- Patients agree to refrain from any type of additional weight loss surgery, reconstructive surgery, or weight-altering medications that would affect body weight.
- Signed consent form from parent or guardian and signed assent for un-emancipated minors.
Who cannot join
- Previous interventional/surgical treatment of obesity or prior gastric surgery.
- Females who are pregnant or lactating.
- Uncontrolled hypothyroidism or adrenal related obesity as determined by the investigator.
- Known congenital or acquired anomalies of the GI tract such as esophageal or cricopharyngeal narrowing or stricture; distorted esophagus, esophageal pouch or pyloric stenosis.
- Severe cardiovascular, cerebrovascular and/or cardiopulmonary disease or other serious organic disease that makes the subject a high-risk candidate as determined by the investigator.
- Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or esophageal varices; or esophageal or gastric disorders including uncontrolled diarrhea, dysmotility, or Barrett's Esophagus.
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- History of malignant hyperthermia, having a prior allergic reaction to general anesthesia, having a known difficult airway, or if the patient is not a candidate for general anesthesia.
- Immunocompromised status such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders or history or presence of pre-existing autoimmune connective tissue disease, i.e., systemic lupus erythematosus or scleroderma as determined by the treating investigator.
- Subjects with uncontrolled psychiatric conditions including eating disorders (e.g., bulimia, binge eating disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5
- Acute or chronic infections (localized or systemic);
- Significant movement limitations of lower extremities (e.g., cannot walk without the use of, or assistance from, a brace, cane, crutch, another person, prosthetic device, wheelchair, or other assistive device or is severely limited in their ability to walk due to an arthritic, neurological, or orthopedic condition).
- Recently (within previous 3 months) prescribed or initiated therapy with medication(s) known to cause significant weight gain or weight loss including but not limited to a glucagon-like peptide-1 (GLP-1) Receptor Agonist, or is likely to require treatment with such medication(s) during the study.
- Currently taking or has taken within the previous 3-months prescription or over-the-counter weight loss medications (e.g., medications and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.). Additionally, the subject must agree to refrain from use of such medications and weight loss/appetite suppressing dietary supplements during the course of the trial including the subject eligibility assessment period;
- Weight loss of at least 5kg within the previous 3 months;
- Patient with documented medical history/diagnosis of a mood disorder including, but not limited to active substance abuse, a history of psychoses, uncontrolled depression, suicidal attempts or current suicidal tendencies or ideations; or documented history of drug and/or alcohol abuse within one year of the screening visit;
- The participant is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study.
- Current cigarette smokers, vaping, alcohol, or marijuana use.
- Patients with connective tissue disorders
- Subjects in whom endoscopic surveillance of the stomach may be required including but not limited to Crohn's disease, Ulcerative Colitis, personal or family history of familial and non-familial adenomatous syndromes, or Lynch syndrome;
- Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study.
- At time of the ESG procedure, if the PI sees any evidence of the following: Hiatal hernia >2 cm, esophageal or gastric varices, ulcers of the stomach and or duodenum, esophageal or duodenal stenosis, or gastric or duodenal polyps, or Gastric Antral Vascular Ectasia.
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
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study Evaluating the Safety and Efficacy of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adolescents
The primary goal of this pilot study is to learn if the use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in adolescents with obesity.
Secondary outcomes will evaluate the effectiveness of Endoscopic Sleeve Gastroplasty (ESG) in long-term reduction of weight, improvements in obesity-related co-morbidities and improvements in quality of life.
Read more
Participants will:
- Have their stomach volume reduced with the ESG procedure (study intervention), rather than with a bariatric surgery, under general anesthesia
- Undergo pregnancy testing (female participants only)
- Be admitted overnight to the hospital for recovery and monitoring following the ESG procedure
- Have a physical examination performed at study follow-up visits
- Participate in surveys about any side effects from the procedure and about quality of life
- Follow-up with the study team.
- Participants will still be seen in the multidisciplinary Bariatrics Clinic team consisting of an obesity medicine doctor, registered dietician, physical activity specialist, and psychologist as part of normal standard of care.
- Conditions
- Obese Adolescents, Obesity, Morbid, Obesity/Therapy
- Being tested
- Endoscopic Sleeve Gastroplasty (ESG) Procedure
- Keywords
- Obesity, Pediatrics, Adolescents, BMI ≥95th percentile, Weight Loss, Weight Management, Endoscopic Sleeve Gastroplasty, Bariatric Procedure
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve Gastroplasty (ESG) ProcedureDevice
The ESG procedure will be performed under general anesthesia monitored by an anesthesiologist. The device that will be used is called the Apollo Endosurgery ESG System, which is the only FDA approved device for the reduction of stomach volume through endoscopic sleeve gastroplasty for adult patients with obesity. This device works by being attached to a standard upper endoscope and is inserted through the mouth and goes into the stomach. When in the stomach, the back and front wall of the stomach will be stitched together to reduce the size of the stomach and help decrease the amount of food a patient can eat and drink at one time before feeling full.
| Study group | Role | What they receive |
|---|---|---|
| ESG Intervention | Experimental | Not described Receives: Device: Endoscopic Sleeve Gastroplasty (ESG) Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in our study population
Number of procedure related adverse events will be collected. Severity of adverse events will be defined using the Clavien-Dindo Classification of Surgical Complications.
Measured: 24 months
Secondary outcomes (13)
Evaluate the effectiveness of ESG in long-term reduction of weight (BMI)
The primary parameter for assessing this objective will be a function of the percent change in BMI.
Measured: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (waist circumference)
Change in waist circumference, measured in centimeters.
Measured: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (obesity class)
Number of subjects who shift in class of obesity (class 3, class 2, and class 1).
Measured: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with unchanged medication use)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c)
Measured: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with decreased medication use)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c )
Measured: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with medication discontinuation)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c)
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing hypertension medication)
Number of subjects with a reduction in anti-hypertensive medication intake with no increase in blood pressure
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing blood pressure)
Number of subjects with a reduction in blood pressure of 10/5mmHg with no increase in medication
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (stage of hypertension)
Number of subjects who show reduction in stage of hypertension (examples include Stage 2 Hypertension to Stage 1 Hypertension or Stage 1 Hypertension to no hypertension)
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia)
Number of subjects with decrease in low-density lipoprotein (LDL) by 10 mg/dL (with no increase in medication)
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia medications)
Number of subjects with reduction in medication intake with no adverse change in dyslipidemia indexes (LDL, TCL/HDL cholesterol ratio)
Measured: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (triglycerides)
Number of subjects with a decrease in fasting triglyceride to <150 mg/dL
Measured: 24 months
Evaluate changes in hunger and satiety
Changes will be measured using a 2-item hunger-satiety questionnaire. This is a 2 item, self-report, measure that will assesses the subjects' hunger and fullness before and post-procedure.
Measured: 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start3 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdolescentsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Michael Manfredi, Children's Hospital of Philadelphia
- Investigators
- Michael Manfredi, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914765
- Sponsor's protocol ID
- 23-021643
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to the small sample size and sole location making study participation potentially identifiable for subjects, we do not plan to make IPD publicly available to other researchers. However, some data may be shared with research collaborators in the future upon obtaining Institutional Review Board approval and subject consent.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Efficacy of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adolescents
- ClinicalTrials.gov ID
- NCT06914765
- Acronym / sponsor ID
- 23-021643
- Conditions
- Obese Adolescents, Obesity, Morbid, Obesity/Therapy
- Keywords
- Obesity, Pediatrics, Adolescents, BMI ≥95th percentile, Weight Loss, Weight Management, Endoscopic Sleeve Gastroplasty, Bariatric Procedure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Apr 2025 (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 primary goal of this pilot study is to learn if the use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in adolescents with obesity.
Secondary outcomes will evaluate the effectiveness of Endoscopic Sleeve Gastroplasty (ESG) in long-term reduction of weight, improvements in obesity-related co-morbidities and improvements in quality of life.
Participants will:
- Have their stomach volume reduced with the ESG procedure (study intervention), rather than with a bariatric surgery, under general anesthesia
- Undergo pregnancy testing (female participants only)
- Be admitted overnight to the hospital for recovery and monitoring following the ESG procedure
- Have a physical examination performed at study follow-up visits
- Participate in surveys about any side effects from the procedure and about quality of life
- Follow-up with the study team.
- Participants will still be seen in the multidisciplinary Bariatrics Clinic team consisting of an obesity medicine doctor, registered dietician, physical activity specialist, and psychologist as part of normal standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESG Intervention | Experimental | Device: Endoscopic Sleeve Gastroplasty (ESG) Procedure |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Female or male, age ≥ 12 years and ≤17 years at the time of study initiation (defined as the time of consent for participation in the pilot study).
- BMI ≥95th percentile to 120% of the 95th percentile on the Centers for Disease Control and Prevention (CDC) growth curve with at least one obesity related comorbidity; OR BMI ≥ 120% of the 95th percentile on the CDC growth curve regardless of the presence or absence of comorbidities. Clinically significant obesity related comorbidities including type 2 diabetes mellitus, idiopathic intracranial hypertension (IIH), non-alcoholic steatohepatitis (NASH) now called metabolic dysfunction-associated steatohepatitis (MASH), Blount's disease, Slipped Capital Femoral Epiphysis (SCFE), sleep apnea defined as AHI ≥ 5, Gastroesophageal Reflux Disease (GERD), hypertension, or dyslipidemia.
- Must have a documented history of weight management and weight loss attempts with supervised diets and exercise programs for at least 6 months from a Healthy Weight provider.
- All female subjects must have a negative serum pregnancy test.
- Has a signed note from a medically supervised weight loss program that the patient demonstrates commitment to nutrition, psychological, and physical activity evaluations and follow-ups in the Healthy Weight clinics, without frequent non-compliance or no-shows.
Key exclusion criteria (21 listed)
- Previous interventional/surgical treatment of obesity or prior gastric surgery.
- Females who are pregnant or lactating.
- Uncontrolled hypothyroidism or adrenal related obesity as determined by the investigator.
- Known congenital or acquired anomalies of the GI tract such as esophageal or cricopharyngeal narrowing or stricture; distorted esophagus, esophageal pouch or pyloric stenosis.
- Severe cardiovascular, cerebrovascular and/or cardiopulmonary disease or other serious organic disease that makes the subject a high-risk candidate as determined by the investigator.
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) ProcedureThe ESG procedure will be performed under general anesthesia monitored by an anesthesiologist. The device that will be used is called the Apollo Endosurgery ESG System, which is the only FDA approved device for the reduction of stomach volume through endoscopic sleeve gastroplasty for adult patients with obesity. This device works by being attached to a standard upper endoscope and is inserted through the mouth and goes into the stomach. When in the stomach, the back and front wall of the stomach will be stitched together to reduce the size of the stomach and help decrease the amount of food a patient can eat and drink at one time before feeling full. | Device | ESG Intervention |
Primary outcome
Determine whether use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in our study population
Time frame: 24 months
Number of procedure related adverse events will be collected. Severity of adverse events will be defined using the Clavien-Dindo Classification of Surgical Complications.
13 secondary outcomes
Evaluate the effectiveness of ESG in long-term reduction of weight (BMI)
Time frame: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (waist circumference)
Time frame: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (obesity class)
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with unchanged medication use)
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with decreased medication use)
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with medication discontinuation)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing hypertension medication)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing blood pressure)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (stage of hypertension)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia medications)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (triglycerides)
Time frame: 24 months
Evaluate changes in hunger and satiety
Time frame: 24-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 10 Dec 2025.
- Individual participant dataSharing planned: No. Due to the small sample size and sole location making study participation potentially identifiable for subjects, we do not plan to make IPD publicly available to other researchers. However, some data may be shared with research collaborators in the future upon obtaining Institutional Review Board approval and subject consent.
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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.
Michael Manfredi, MD principal investigator
Children's Hospital of Philadelphia
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) Procedure in people with Obese Adolescents and Obesity, Morbid, run by Children's Hospital of Philadelphia 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 12 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: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. 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?
Determine whether use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in our study population (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.