Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

Inclusion Criteria: * 18 years or older. * Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss. * Willing to have a TORe procedure for the treatment of weight regain. * BMI between 30 and 50 kg/m2, inclusive. * GJA diameter ≥ 20 mm, confirmed either during a * Screening EGD completed ≤ 60 days from study procedure or * EGD performed immediately prior to the TORe procedure. * 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). * Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study. * Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study. * Agrees 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. * Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System. Exclusion Criteria: * Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins). * Current or planned management of Type 2 Diabetes with incretin medications. * Inability or unwillingness 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. * Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years. * Vulnerable subject.