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

Boston Scientific

Status: Enrolling

Conditions: Weight Loss; Weight Regain

Treatments: Device: TORe with OverStitch; Behavioral: Intensive lifestyle modification

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015424

E7220

Details and patient eligibility

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

TORe and Lifestyle Modification Arm

Active Comparator group

Description:

Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study

Treatment:

Behavioral: Intensive lifestyle modification

Device: TORe with OverStitch

Lifestyle Modification Arm

Active Comparator group

Description:

Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.

Treatment:

Behavioral: Intensive lifestyle modification