EndoZip versus Apollo ESG for weight loss in people with obesity

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.

This test will see if the EndoZip procedure helps adults with obesity who haven't lost weight through non-surgical methods lose more weight and is as safe as the Apollo ESG procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Nitinotes Surgical Ltd. (Industry-sponsored)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT07090005 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter, prospective, blinded, two-arm study will enroll up to 184 adults with BMI 30–50 kg/m² who failed non-surgical weight-loss efforts and randomize them to receive either the EndoZip system or the Apollo ESG (OverStitch) procedure. Patients will be enrolled at up to 10 sites in the United States and Europe, with as many as 30 patients per site, and followed for 12 months. The protocol includes a medically supervised diet and behavior modification program and regular safety and effectiveness assessments, including weight loss and adverse event monitoring. The study also includes a quota to ensure at least 46 participants with hypertension treated with two or more antihypertensive medications who have been controlled for at least six months are enrolled.

Who should consider this trial

Good fit: Adults aged 21–65 with BMI 30–50 kg/m² who have failed non-surgical weight-loss methods, can follow required dietary and behavioral changes, and can attend scheduled follow-up visits are the intended candidates.

Not a fit: People outside the age or BMI criteria, those unable or unwilling to adhere to diet/behavior changes or follow-up visits, pregnant women, or patients with contraindications to endoscopic procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the EndoZip procedure could provide an additional minimally invasive endoscopic option that achieves meaningful weight loss with an acceptable safety profile compared with current ESG techniques.

How similar studies have performed: Prior studies of the OverStitch ESG technique have demonstrated meaningful weight loss, while the EndoZip system is newer and has limited published clinical data to date.

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.

Where this trial is running

Los Angeles, California and 1 other locations

• Cedars Sinai Medical Center — Los Angeles, California, United States (Active_not_recruiting)
• Lenox Hill Hospital | Northwell Health — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Ravit Peled

Conditions Obesity; Overweight