Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure

Prior treatment

• Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy).
• A known hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy.
• Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid)
• Patients receiving daily prescribed treatment with high dose aspirin (\> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants or on low dose aspirin and cannot come of medication for a total of 10 days peri procedure.
• Patients with history or current abuse of drugs or alcohol
• Patients who are unable or unwilling to take prescribed Proton Pump Inhibitor (PPI) medication
• Patients who are taking medications that cause weight loss within the last 6 months
• Patients are currently on medications that are known to affect gastric emptying, such as anti-seizure or anti-arrhythmic medications and / or poorly-controlled Glycemia
• Patients who are taking corticosteroids, immunosuppressants, or narcotics and cannot come of medication for the study period.

Other illness

• Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions.
• Patients with any inflammatory disease
• Patients with history of cancer in the gastrointestinal tract.
• Potential upper gastrointestinal bleeding conditions such as a history of angioectasias.
• Patient with motility disorders of the GI tract or intractable constipation
• Type 1 diabetes or Type 2 diabetes with a HgbA1c \>9 and/or injectable medications or likely requiring insulin treatment in the following 12 months.
• Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Patients with hepatic insufficiency or cirrhosis (CAB\>290 Db/m or Fibrosis score \>10 kPa)
• Patients with viral and / or autoimmune hepatitis
• Presence of any other form of chronic liver disease
• Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 12 months and / or poorly-controlled hypertension

Lab values

• Patients with known coagulation disorder (INR \>1.5) or on anticoagulation therapy.

Other

• A known gastric mass or gastric polyps \> 1 cm in size.
• Patients with TG \>500 or LDL \>190
• Patients with BP \>180 / 110
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• Patients with chronic abdominal pain
• Any contraindication to liver biopsy
• Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose of ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline
• Patients that used an intragastric device for weight loss
• Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher.
• Patients who are pregnant or breast-feeding.

• Age 21-75
• BMI ≥ 27 and ≤40 kg/m².
• Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
• Patients with 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.
• 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.
• At least 50% of the population included in the study diagnosed with Type 2 diabetes (T2D), and with HbA1c \< 9 at least 6 months prior to study enrollment, excluding Insulin-dependent.
• At least 50% of the population included in the study diagnosed with hypertension, treating with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment.