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Study identifier: NCT07015424 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Weight Regain · Weight Loss  ·  Sponsor: Boston Scientific Corporation

PhaseNA
Planned participants108
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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.

This description comes directly from the study's public registry record.

Talk to the study team

Victoria Lazzari  ·  508-561-7296  ·  victoria.lazzari@bsci.com

Always discuss trial participation with your own doctor first.

Locations (9)

Hoag Memorial HospitalIrvine, California, United StatesRecruiting
Stanford University Medical CenterStanford, California, United StatesNot Yet Recruiting
Mayo ClinicJacksonville, Florida, United StatesRecruiting
Orlando Health IncOrlando, Florida, United StatesRecruiting
University of South FloridaTampa, Florida, United StatesNot Yet Recruiting
Rush University Medical CenterChicago, Illinois, United StatesNot Yet Recruiting
Mayo Clinic FoundationRochester, Minnesota, United StatesRecruiting
NYU Grossman School of MedicineNew York, New York, United StatesNot Yet Recruiting
University of Texas Houston Health Science CenterHouston, Texas, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07015424