NCT07015424 · Boston Scientific Corporation
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
(REIGNITE)
What this study 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 randomly assigned 2:1.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Irvine, California
- Stanford, California
- Jacksonville, Florida
- Orlando, Florida
- Tampa, Florida
- Chicago, Illinois
- Rochester, Minnesota
- New York, New York
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations