Clinical Trial

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

Study acronym: REIGNITE
Recruiting
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Summary
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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2025-06-03; most recent amendment 2026-07-07.
Status change: Not Yet Recruiting → Recruiting 2026-02-03
Trial Details
NCT Number NCT07015424
Lead Sponsor Boston Scientific Corporation
Conditions Weight Regain, Weight Loss
Enrollment 108 participants
Start Date 2026-04-14
Primary Completion 2026-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-08