RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Boston Scientific Corporation • ClinicalTrials.gov ID: NCT07015424

Registry updated: 2026-10-13

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Description

The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to 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 moderate to 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.

Interventions

TORe with OverStitch (Device)
Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
Intensive lifestyle modification (Behavioral)
Moderate to intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician.

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 ≤ 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.

Conditions

Weight Regain Weight Loss

Locations

Hoag Memorial Hospital — Irvine, California, United States
Stanford University Medical Center — Stanford, California, United States
Mayo Clinic — Jacksonville, Florida, United States
Orlando Health Inc — Orlando, Florida, United States
University of South Florida — Tampa, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Mayo Clinic Foundation — Rochester, Minnesota, United States
NYU Grossman School of Medicine — New York, New York, United States
Northwell Health — New York, New York, United States
University of Texas Houston Health Science Center — Houston, Texas, United States
West Virginia University Hospital — Morgantown, West Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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