Comparing Outcomes of Classic Transoral Outlet Reduction (TORe) Versus Endoscopic Submucosal Dissection-TORe: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adult patients with history of Roux-en-Y gastric bypass and weight regain

• Dilated gastrojejunal anastamosis as diagnosed on endoscopy

• Patients undergoing standard of care for treatment of obesity with endoscopic revisional procedure (a.k.a. TORe) who are enrolled in the GI Bariatric Endoscopy program and clinic at the study site

Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
C. Roberto Simons-Linares, MD
bariatricendoscopy@ccf.org
2164448460
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2026-04
Participants
Target number of participants: 70
Treatments
Experimental: E-TORe
Participants in this arm received the E-TORe procedure
Active_comparator: c-TORe
Participants in this arm received the classical or c-TORe procedure
Related Therapeutic Areas
Sponsors
Leads: Carlos Roberto Simons-Linares

This content was sourced from clinicaltrials.gov