Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
The goal of this clinical trial is to evaluate weight loss with 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 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 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.
Sponsor: Boston Scientific Corporation
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07015424 · last updated 2026-07-08