Actively Recruiting
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Led by Boston Scientific Corporation · Updated on 2026-04-28
108
Participants Needed
9
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Experienced weight regain of at least 20% from lowest weight after clinically successful weight loss
- Willing to have a TORe procedure for weight regain treatment
- Body Mass Index (BMI) between 30 and 50 kg/m2, inclusive
- Gastrojejunal anastomosis (GJA) diameter of 20 mm or more confirmed by endoscopy
- Anatomically suitable for the procedure, including pouch size less than 6 cm in length
- Agree not to take additional weight loss supplements or medications during the first 6 months
- On a stable dose of anti-diabetic medication for at least three months with no planned changes during the first 6 months
- Agree to follow study requirements and provide informed consent
- Meet indications for TORe procedure with OverStitch Endoscopic Suturing System
You will not qualify if you...
- Current or recent (within 3 months) use of weight loss supplements or medications, including incretins
- Current or planned treatment of Type 2 Diabetes with incretin medications
- Unable or unwilling to comply with treatment or study visit requirements
- Medical judgment that participant is not a candidate for the TORe procedure
- Current pregnancy, planned pregnancy, or breastfeeding within the next two years
- Vulnerable subject status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Hoag Memorial Hospital
Irvine, California, United States, 92618
Not Yet Recruiting
2
Stanford University Medical Center
Stanford, California, United States, 94305
Not Yet Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Orlando Health Inc
Orlando, Florida, United States, 32806
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33606
Not Yet Recruiting
6
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
7
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
NYU Grossman School of Medicine
New York, New York, United States, 10016
Not Yet Recruiting
9
University of Texas Houston Health Science Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
V
Victoria Lazzari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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