Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients

Launched by NITINOTES SURGICAL LTD. · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different weight loss procedures—the EndoZip™ system and the Apollo Endoscopic Suturing Gastroplasty (ESG)—to see which one is more effective and safe for people who are obese and have not lost weight through diet, exercise, or other non-surgical methods. Both procedures involve using an endoscope, a thin tube with a camera, to help reduce the size of the stomach without open surgery. After the procedure, participants will also follow a medically supervised diet and behavior program to support their weight loss.

People between the ages of 21 and 65 with a body mass index (BMI) between 30 and 50 may be eligible if they have tried other weight loss methods without success and are willing to commit to the lifestyle changes required. The study is looking for about 184 participants, including groups of people with obesity alone, obesity with high blood pressure, obesity with type 2 diabetes (controlled with pills, not insulin), or obesity with both conditions. Participants will need to attend regular follow-up visits, complete questionnaires about their quality of life, and undergo lab tests. Important to know is that the study excludes anyone with certain health issues, prior stomach surgeries, or conditions that might make the procedures unsafe, as well as those who are pregnant or breastfeeding. This trial is not yet recruiting, but it aims to find better options for people struggling with weight loss through non-surgical means.

Gender

ALL

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.