TORe and Lifestyle Changes for Weight Regain After Gastric Bypass

The goal of this clinical trial is to evaluate weight loss with Transoral Outlet Reduction (TORe) and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass.

Participants will be randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized to the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Are experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
• Are willing to have a TORe procedure for the treatment of weight regain.
• Have a BMI between 30 and 50 kg/m2, inclusive.
• Are anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment. (Pouch that is shorter than 6 cm in length.)
• Agree not to take additional over the counter or prescribed weight loss supplements/medications (including incretins) during the first 6 months of the study.
• Are on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.
• Agree to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study.
• Meet the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.

You will be excluded from the study if any of the following criteria apply to you:

• Are currently using, or have used within the three months prior to the baseline visit, over the counter or prescribed weight loss supplements/medications (including incretins).
• Have current or planned management of Type 2 diabetes with incretin medications.
• Are not able or willing to comply with assigned treatment or protocol requirements related to visits.
• Investigator's medical judgement that the subject is not a candidate for the TORe procedure.
• Are currently pregnant confirmed by site standard of care or have a planned pregnancy or breastfeeding in the next two years.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.