Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure (CL00010)
Obesity

About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria: 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. 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 disease Patients 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 >190 Patients with BP >180 / 110 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. 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 constipation Patients 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 endoscopy Patients with chronic abdominal pain 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 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) 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 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 pregnant or breast-feeding. Patients who are taking medications that cause weight loss within the last 6 months 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 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.
Sites / Locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Arms of the Study
Arm 1
Experimental
EndoZip System
The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.