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

Launched by BOSTON SCIENTIFIC CORPORATION · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help people who have regained weight after having gastric bypass surgery. Researchers want to see how effective a procedure called Transoral Outlet Reduction (TORe) combined with lifestyle changes, like a balanced diet and exercise, is compared to just making those lifestyle changes alone. Participants will be divided into two groups: one group will receive the TORe procedure and lifestyle support, while the other group will only focus on lifestyle changes for the first six months. After that, the second group will have the option to receive the TORe procedure if they choose.

To be eligible for this study, participants must be at least 18 years old and have regained a significant amount of weight (20% or more) after their initial weight loss from gastric bypass surgery. They should also have a Body Mass Index (BMI) between 30 and 50 and be willing to undergo the TORe procedure. Participants will be followed for a total of 24 months, so they can expect regular check-ins and support throughout the study. It's important to note that those interested should not be using any weight loss medications or supplements during the study period. This trial is not yet recruiting participants, but it's an opportunity for individuals looking for help with weight regain after surgery.

Gender

ALL

Eligibility criteria

• 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 ≤ 30 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 12 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 one month 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.