Transoral outlet reduction plus lifestyle program for weight regain after gastric bypass
Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass
This trial will test whether adding a transoral outlet reduction procedure to an intensive lifestyle program helps people who regained weight after Roux-en-Y gastric bypass lose more weight than lifestyle changes alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 9 sites (Irvine, California and 8 other locations) |
| Trial ID | NCT07015424 on ClinicalTrials.gov |
What this trial studies
Participants are randomized 2:1 to receive either a transoral outlet reduction (TORe) using the OverStitch device plus an intensive lifestyle modification program or the lifestyle program alone, with the lifestyle-only group eligible for TORe after 6 months. The lifestyle program includes a calorie-restricted balanced diet, exercise guidance, and coaching; the TORe arm receives endoscopic suturing of the gastrojejunal outlet. Key eligibility includes age ≥18, BMI 30–50 kg/m2, ≥20% weight regain from nadir, and a gastrojejunal anastomosis (GJA) diameter ≥20 mm; pouch anatomy must not require surgical reduction. Participants are followed for 24 months to compare weight loss and maintenance between groups.
Who should consider this trial
Good fit: Adults (18+) with BMI 30–50 who have regained at least 20% of their weight from their lowest post-bypass weight after Roux-en-Y and who have an enlarged gastrojejunal outlet (GJA ≥20 mm) are the intended participants.
Not a fit: People without significant outlet enlargement (GJA <20 mm), those with very large pouches requiring surgical revision, or those who cannot undergo endoscopy or follow the lifestyle program are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive option to reduce an enlarged gastrojejunal outlet and help people maintain greater weight loss after gastric bypass.
How similar studies have performed: Prior smaller studies and case series of endoscopic transoral outlet reduction using OverStitch have shown modest short-term weight loss, but long-term randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 8 other locations
- Hoag Memorial Hospital — Irvine, California, United States (Not_yet_recruiting)
- Stanford University Medical Center — Stanford, California, United States (Not_yet_recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Orlando Health Inc — Orlando, Florida, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Not_yet_recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- Mayo Clinic Foundation — Rochester, Minnesota, United States (Recruiting)
- NYU Grossman School of Medicine — New York, New York, United States (Not_yet_recruiting)
- University of Texas Houston Health Science Center — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Victoria Lazzari
- Email: victoria.lazzari@bsci.com
- Phone: 508-561-7296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.