Comparing Reduction With ESD- Versus APC-TORe
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
🗓️ Study Start (Actual) 2 October 2023
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion 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

    Exclusion Criteria:

    • * 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 N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 9 November 2023
  • First Submitted that Met QC Criteria 9 November 2023
  • First Posted 14 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024