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Study on TORe and Lifestyle Changes for Weight Regain After Gastric Bypass

This study is for people who have regained weight after having gastric bypass surgery. It compares two approaches: Transoral Outlet Reduction (TORe) with OverStitch (a device that helps reduce the size of the stomach outlet) combined with an intensive lifestyle program, versus the intensive lifestyle program alone. The lifestyle program includes a healthy diet, exercise, and coaching. The main goal is to see how much weight participants lose after 6 months. You might be able to join if you are 18 or older, have regained at least 20% of your weight after successful weight loss, and have a body mass index (BMI) between 30 and 50. Your stomach outlet (GJA diameter) also needs to be at least 20 mm.

Study design
This is an interventional study planning to enroll 108 participants. Participants will be randomly assigned to one of two groups, with two-thirds receiving TORe and lifestyle changes, and one-third receiving lifestyle changes alone.
What's involved
Participants will receive either a TORe procedure and an intensive lifestyle modification program, or just the lifestyle modification program. Those in the lifestyle modification alone group can receive a TORe procedure after 6 months. The total follow-up period for the study is 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 24 months after enrollment.

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NCT07015424

Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~108 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:TORe with OverStitchIntensive lifestyle modification

At a glance

Recruiting sites
5 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Body Weight Loss
Measured over 6 Months post enrollment

Conditions

Weight Regain
Weight Loss

Explore related trials

Weight Gain

Where it's being run

9 sites across 6 states
Florida3
California2
Illinois1
Minnesota1
New York1
Texas1

Who to contact

Victoria Lazzari
[email protected]
508-561-7296
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Total Body Weight Loss6 Months post enrollment

    The percent TBWL that subjects achieve at 6 months post-randomization