Transoral outlet reduction plus lifestyle program for weight regain after gastric bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 treatment visit of over the counter or prescribed weight loss supplements / medications (including incretins).
* Current or planned management of any obesity-related comorbidity 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 it's running

• Hoag Memorial Hospital
  Irvine, California, United States Recruiting
• Stanford University Medical Center
  Stanford, California, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Orlando Health Inc
  Orlando, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Victoria Lazzari
• Email: victoria.lazzari@bsci.com
• Phone: 508-561-7296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.