Comparing Reduction With ESD- Versus APC-TORe

Description

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.

Conditions

Obesity, Roux-en-y Anastomosis Site, Weight Gain

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Study Overview

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Study Details

Study overview

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.

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

Comparing Reduction With ESD- Versus APC-TORe

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Prior revision of gastric bypass
  • * Active and uncontrolled gastro-esophageal reflux disease defined as ≥ grade C esophagitis
  • * Active untreated Helicobacter pylori infection
  • * Malignancy newly diagnosed by endoscopy
  • * Upper gastro-intestinal conditions such as ulcers, polyps, gastric varices, strictures, congenital or acquired intestinal telangiectasia or other abnormalities that preclude completion of TORe
  • * Presence of gastrogastric or gastroenteric fistula
  • * Inability to undergo general anesthesia
  • * Participating in another ongoing clinical trial of an investigational weight loss drug or device
  • * Active pregnancy
  • * Use of anticoagulation therapy or P2Y12 inhibitors which cannot be discontinued for the time frame surrounding the procedure
  • * Insulin-dependent diabetes mellitus
  • * Unwillingness to comply with standard post-TORe dietary guidelines and follow-up care
  • * Any other anatomical, technical or otherwise factor that limits the ability of the endoscopist to perform either E-TORe or c-TORe
  • * Any additional factor, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the trial protocol

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Carlos Roberto Simons-Linares,

C. Roberto Simons-Linares, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-04