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Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
NCT07015424 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07015424 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07015424?
The interventions under investigation include: TORe with OverStitch (DEVICE), Intensive lifestyle modification (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07015424?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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