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

Inclusion criteria

• BMI ≥ 30 and ≤50 kg/m².
• Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
• History of failure with non-surgical weight-loss methods.
• 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.
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
• Ability to give informed consent.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• 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

• History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
• Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
• Prior open or laparoscopic bariatric surgery.
• Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
• 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.
• 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.
• A gastric mass or gastric polyps \> 1 cm in size.
• A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• Achalasia or any other severe esophageal motility disorder
• Severe coagulopathy (INR \>1.5) or on anticoagulation therapy.
• 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.
• Diabetics who are treated with GLP-1 and have lost 5% or more of their weight (%TBWL ≥ 5%).
• 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.
• Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Chronic abdominal pain
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
• Hepatic insufficiency or cirrhosis
• Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
• Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
• Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
• Patients who are pregnant or breast-feeding.
• 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
• Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti- arrhythmic medications
• Patients who are taking corticosteroids, immunosuppressants, and narcotics
• Patients who are taking diet pills
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
• Specific diagnosed genetic disorder such as Prader Willi syndrome.
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.