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NCT07015424 · ClinicalTrials.gov registry record · NA
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
A NA study of Weight Loss and Weight Regain, sponsored by Boston Scientific Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 10
- Study locations
NCT07015424: Recruiting NA study of Weight Loss and Weight Regain, sponsored by Boston Scientific Corporation.
NCT07015424 is a NA study of Weight Loss and Weight Regain that is actively recruiting participants, run by Boston Scientific Corporation. The registered enrollment target is 108 participants, below the 1,500-participant average among 116 other Weight Loss trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015424, a NA study of Weight Loss and Weight Regain, is actively recruiting participants, sponsored by Boston Scientific Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The percent TBWL that subjects achieve at 6 months post-randomization
Conditions Studied
Interventions
- DEVICE TORe with OverStitch
- BEHAVIORAL Intensive lifestyle modification
Study Locations (10)
Florida
- Mayo Clinic - Jacksonville
- Orlando Health Inc - Orlando
- University of South Florida - Tampa
California
- Hoag Memorial Hospital - Irvine
- Stanford University Medical Center - Stanford
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic Foundation - Rochester
New York
- NYU Grossman School of Medicine - New York
Texas
- University of Texas Houston Health Science Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-02 |
| Est. Completion | 2028-11 |
| Phase | NA |
What NCT07015424 shows while recruiting
NCT07015424 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,500-participant average among 116 other Weight Loss trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Weight Loss appearing as the primary indexed condition, and to 2 interventions - of which TORe with OverStitch is the first listed.
NCT07015424 lists 10 locations in 7 states (Florida, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT07015424 about?
NCT07015424 is a clinical study titled "Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass". 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 ...
What is the current status of trial NCT07015424?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2026-02. Estimated completion is 2028-11.
What conditions does trial NCT07015424 study?
This clinical trial studies the following conditions: Weight Loss, Weight Regain.
What interventions are being tested in trial NCT07015424?
The interventions under investigation include: TORe with OverStitch (DEVICE), Intensive lifestyle modification (BEHAVIORAL).
Who is sponsoring clinical trial NCT07015424?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07015424 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07015424's enrollment target sits among peer trials
108 44th of 116 higher than 73 of 116 other Weight Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Weight Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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