RECRUITING

Comparing Reduction With ESD- Versus APC-TORe

Conditions

Obesity Roux-en-y Anastomosis Site Weight Gain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-02

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06131281

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

C. Roberto Simons-Linares, MD

CONTACT

2164448460

bariatricendoscopy@ccf.org

Principal Investigator

C. Roberto Simons-Linares, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Carlos Roberto Simons-Linares

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02

Study Completion Date2025-04

Study Record Updates

Study Start Date2023-10-02

Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Roux-en-y Anastomosis Site
Weight Gain