Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
Comparing the Efficacy and Safety of the EndoZipTM System and Apollo Endoscopic Sleeve Gastroplasty (ESG), Followed by Behavioral Modifications, in Obese Patients Who Have Not Achieved Weight Reduction Through Non-surgical Methods.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients who meet the eligibility criteria will be follow up for 12 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares how well the EndoZip and Apollo ESG procedures work and how safe they are. It is for adults ages 21–65 with obesity who have not had success with weight-loss methods that do not involve surgery.
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 21–65 years old.
- Your BMI is 30–50. BMI is a measure of weight compared with height.
- You have tried weight-loss methods without surgery, but they did not work.
- You agree to the required food and behavior changes and a medically supervised weight-loss program.
- You can give informed consent, meaning you understand the study and agree to join.
- You agree to blood tests, a questionnaire about weight and quality of life, and regular visits. You live close enough to attend all visits.
- If you can become pregnant, you agree to use adequate birth control.
- The study needs at least 46 people whose high blood pressure has been well controlled with 2 or more medicines for at least 6 months. It also needs at least 46 people with type 2 diabetes treated only with pills and an A1c of 9 or less for at least 6 months. A1c measures average blood sugar.
Who can't join
- You have had weight-loss surgery, surgery on your food pipe or stomach, hiatal hernia surgery, or other digestive tract surgery. Gallbladder or appendix removal without problems is allowed. Prior devices placed in the stomach or internal scar tissue may also rule you out.
- You have certain digestive tract problems, such as inflammation, ulcers, cancer, bleeding risks, a stomach lump, polyps larger than 1 cm, a hiatal hernia larger than 4 cm, or severe acid reflux. Problems passing a viewing tube, swallowing, moving food through the gut, ongoing belly pain, or severe constipation also rule you out.
- You need insulin, are likely to need it within 12 months, or have an A1c above the study's limit. Certain weight-loss results while taking or after stopping GLP-1 diabetes medicines also rule you out.
- You have a serious bleeding disorder, liver failure or liver scarring, serious heart or lung disease, poorly controlled blood pressure, or another illness that makes a procedure with a viewing tube unsafe.
- You take certain medicines, including blood thinners, prescribed aspirin above 80 mg daily, anti-inflammatory drugs, stomach-irritating drugs, steroids, medicines that weaken immunity, narcotic pain medicines, or diet pills. Some medicines taken at fixed times may also rule you out. You cannot or will not take the required acid-reducing medicine.
- You are pregnant or breastfeeding.
- You have mental health problems that prevent you from following the lifestyle program, an eating disorder, or are unwilling to follow the supervised diet, behavior program, and regular visits.
- You have a weakened immune system, an autoimmune connective tissue disease such as lupus, certain genetic disorders such as Prader-Willi syndrome, or a hormone disorder that affects weight, such as an underactive thyroid that is not controlled.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age 21-65 2. BMI ≥ 30 and ≤50 kg/m². 3. Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure. 4. History of failure with non-surgical weight-loss methods. 5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program. 6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits. 7. Ability to give informed consent. 8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. 9. \*\*\* There will be a quota for at least a) 46 patients with hypertension treated with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment , b) 46 patients with type II diabetes mellitus on oral agents only with HgbA1c ≤ 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. Thus the cohort of 184 patients will be stratified into four groups (Obesity, Obesity \& HTN, Obesity \& DM, obesity \&HTN \&DM) and block randomized. Exclusion Criteria: 1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy) 2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. 3. Prior open or laparoscopic bariatric surgery. 4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery. 5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease. 6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 7. A gastric mass or gastric polyps \> 1 cm in size. 8. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms. 9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. 10. Achalasia or any other severe esophageal motility disorder 11. Severe coagulopathy (INR \>1.5) or on anticoagulation therapy. 12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ \> 9. 13. Diabetics who are treated with GLP-1 and have lost 5% or more of their weight (%TBWL ≥ 5%). 14. Patients who discontinued GLP-1 therapy and regained less than 80% of the weight they had lost prior to starting GLP-1 treatment and within 3 months of discontinued GLP-1 therapy. 15. Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy 16. Chronic abdominal pain 17. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation 18. Hepatic insufficiency or cirrhosis 19. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing. 20. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist 21. Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up. 22. Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants. 23. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication 24. Patients who are pregnant or breast-feeding. 25. Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs 26. Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti- arrhythmic medications 27. Patients who are taking corticosteroids, immunosuppressants, and narcotics 28. Patients who are taking diet pills 29. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. 30. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer. 31. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised. 32. Specific diagnosed genetic disorder such as Prader Willi syndrome. 33. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating 34. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
Study sites (4)
CA
- Cedars Sinai Medical Center · Los Angeles, CA 90048Sara Karameh, Study Coordinator · Study contact · 202-948-6396 · Sara.Karameh@cshs.orgBarham Abu Dayyeh, MD · Principal investigatorMore trials in Los Angeles
FL
- Orlando Health, Inc. · Orlando, FL 32806Leticia s Morales, MHA, CCRP Supervisor · Study contact · 321-841-9623 · Leticia.Morales@orlandohealth.comAndre Teixeira, MD · Principal investigatorManoel Galvao - Neto, MD · Sub-investigatorMore trials in Orlando
NY
- Weill Cornell -1300 York Avenue · New York, NY 10065Oliver Laguerre, Assistant Research Coordinator · Study contact · 646-962-2085 · oll4007@med.cornell.eduReem Z Sharaiha, MD · Principal investigatorMore trials in New York
- Lenox Hill Hospital | Northwell Health · New York, NY 10075Steven Shamah, MD · Study contact · 973-699-9328 · steven.shamah@gmail.comSteven Shamah, MD · Principal investigatorMore trials in New York