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 treatment visit of over the counter or prescribed weight loss supplements / medications (including incretins).
• Current or planned management of any obesity-related comorbidity 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.