ReIgnite
Prospective, RandomizEd Clinical Study EvaluatInG TraNsoral Outlet ReductIon (TORe) and Lifestyle Modification for Patients with WeighT REgain Following Roux-en-Y Gastric ByPass
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Clinical Trial Information
Trial Contact: Morales, Leticia
Trial Phone: 321.841.9623
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IRB No: 25.286.10
Protocol Abbrev: ReIgnite
Principal Investigator: Andre F. Teixeira, MD
Phase: Device: Phase IV
Age Group: Adult
Secondary Protocol No: E7220
Treatment: TORe procedure-Transoral outlet reduction (TORe) procedure is performed to reduce the size of the stroma and dilated pouch by placing sutures (1 to 3 sutures) using the OverStitch™ or OverStitch NXT™ Endoscopic Suturing System (ESS).
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT07015424
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Objective
To evaluate the weight loss with Transoral Outlet Reduction (TORe) using OverStitch™ or Overstitch NXT™ Endoscopic Suturing System and moderate to intensive lifestyle modification versus moderate to intensive lifestyle modification alone for patients that regain weight following Roux-en-Y gastric bypass (RYGB).
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Key Eligibility
Subjects must satisfy all these criteria to be eligible for the study:
1. 18 years or older.
2. Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
3. Willing to have a TORe procedure for the treatment of weight regain.
4. BMI between 30 and 50 kg/m2, inclusive.
5. GJA diameter ≥ 20 mm, confirmed either during a
a. Screening EGD completed ≤ 60 days from Study Treatment visit or
b.EGD performed immediately prior to the randomization and Study Treatment visit.
6. Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch < 6 cm in length).
7. Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months following the TORe procedure.
8. Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.
9. 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.
10. Meets the indications for TORe procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System
