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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06131281). This is a study registration, not published results. Lead sponsor: Stephen Firkins. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Obesity, Roux-en-y Anastomosis Site, Weight Gain. Interventions: PROCEDURE: E-TORe; PROCEDURE: c-TORe. Primary outcome measures: Weight change at 6 months , 6 months from procedure date; Weight change at 12 months , 12 months from procedure date. Brief summary: The goal of this clinical trial is to compare two variations of the same procedure used to assist with weight loss in patients who have a history of Roux-en-Y gastric bypass who have experienced weight regain. The procedure being studied is called the Transoral Outlet Reduction (TORe), and the trial will compare two different ways to complete the TORe procedure. The main question\[s\] it aims to answer are: * Which variation of the TORe procedure results in more weight loss? * Which variation of the TORe is safer? Participants who are eligible and willing to undergo the TORe procedure to assist with weight loss will have the procedure completed either one of the two ways. All other care will be exactly the same between the two groups. Researchers will compare outcomes between the two procedure variations, looking at which one results in more weight loss, is more successful, and safer.