NCT07015424 Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
| NCT ID | NCT07015424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Weight Regain |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2026-04-14 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 18 years or older. * Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss. * Willing to have a TORe procedure for the treatment of weight regain. * BMI between 30 and 50 kg/m2, inclusive. * GJA diameter ≥ 20 mm, confirmed either during a * Screening EGD completed ≤ 60 days from study procedure or * EGD performed immediately prior to the TORe procedure. * Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length). * Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study. * Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study. * Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study. * Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System. Exclusion Criteria: * Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins). * Current or planned management of Type 2 Diabetes with incretin medications. * Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits. * Investigator's medical judgement that the subject is not a candidate for the TORe procedure. * Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years. * Vulnerable subject.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07015424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Weight Regain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07015424 currently recruiting?
Yes, NCT07015424 is actively recruiting participants. Contact the research team at victoria.lazzari@bsci.com for enrollment information.
Where is the NCT07015424 trial being conducted?
This trial is being conducted at Irvine, United States, Stanford, United States, Jacksonville, United States, Orlando, United States and 5 additional locations.
Who is sponsoring the NCT07015424 clinical trial?
NCT07015424 is sponsored by Boston Scientific Corporation. The trial plans to enroll 108 participants.