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

multicenter, prospective, single arm study will include up to 45 patients, (up to 30 patients per site), aimed at evaluating the performance of the EndoZip System in obese patients with type 2 diabetes and / or hypertension who failed to reduce weight with non-surgical weight-loss methods.Patients will be enrolled in 2 clinical sites in Europe. Patients who meet the eligibility criteria is expected to come the clinic for at least 10 visits.

Inclusion Criteria:Age 21-75BMI ≥ 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.Exclusion Criteria:Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy).Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions.Patients with any inflammatory diseasePatients with history of cancer in the gastrointestinal tract.Potential upper gastrointestinal bleeding conditions such as a history of angioectasias.A known gastric mass or gastric polyps > 1 cm in size.Patients with TG >500 or LDL >190Patients with BP >180 / 110A 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.A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.Patient with motility disorders of the GI tract or intractable constipationPatients with known coagulation disorder (INR >1.5) or on anticoagulation therapy.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 endoscopyPatients with chronic abdominal painPatients with hepatic insufficiency or cirrhosis (CAB>290 Db/m or Fibrosis score >10 kPa)Patients with viral and / or autoimmune hepatitisPresence of any other form of chronic liver diseaseRecent (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)Any contraindication to liver biopsyRecent (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 pentoxifyllinePatients that used an intragastric device for weight lossPatients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher.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 alcoholPatients who are unable or unwilling to take prescribed Proton Pump Inhibitor (PPI) medicationPatients who are pregnant or breast-feeding.Patients who are taking medications that cause weight loss within the last 6 monthsPatients 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 hypertensionPatients are currently on medications that are known to affect gastric emptying, such as anti-seizure or anti-arrhythmic medications and / or poorly-controlled GlycemiaPatients who are taking corticosteroids, immunosuppressants, or narcotics and cannot come of medication for the study period.