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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07015424
The ClinicalTrials.gov registry entry for NCT07015424 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,500-participant average among 116 other Weight Loss trials with a reported enrollment target (93% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.