Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Public ClinicalTrials.gov record NCT07015424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to 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 moderate to 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.
Study identification
- NCT ID
- NCT07015424
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Interventions
- TORe with OverStitch Device
- Intensive lifestyle modification Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2026 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Jul 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hoag Memorial Hospital | Irvine | California | 92618 | Recruiting |
| Stanford University Medical Center | Stanford | California | 94305 | Recruiting |
| Mayo Clinic | Jacksonville | Florida | 32224 | Recruiting |
| Orlando Health Inc | Orlando | Florida | 32806 | Recruiting |
| University of South Florida | Tampa | Florida | 33606 | Recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Not yet recruiting |
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | Recruiting |
| NYU Grossman School of Medicine | New York | New York | 10016 | Recruiting |
| Northwell Health | New York | New York | 10075 | Not yet recruiting |
| University of Texas Houston Health Science Center | Houston | Texas | 77030 | Recruiting |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07015424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07015424 live on ClinicalTrials.gov.