Comparing two methods for weight loss after gastric bypass

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

This study is testing two different ways to help people who have gained weight after gastric bypass surgery lose weight again, to see which method works better and is safer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06131281 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two variations of the Transoral Outlet Reduction (TORe) procedure for patients who have regained weight after Roux-en-Y gastric bypass. The study will evaluate the effectiveness and safety of the E-TORe method, which incorporates endoscopic submucosal dissection, against the traditional c-TORe method that uses argon plasma coagulation. Participants will undergo one of the two procedures, and outcomes will be assessed to determine which method leads to greater weight loss and fewer complications. The trial is designed to provide insights into optimizing weight loss interventions for this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with a history of Roux-en-Y gastric bypass who have experienced weight regain and have a dilated gastrojejunal anastamosis.

Not a fit: Patients who have had prior revisions of gastric bypass or have active gastrointestinal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer weight loss options for patients who have regained weight after gastric bypass surgery.

How similar studies have performed: Previous studies have shown that the traditional c-TORe method results in significant weight loss, but the E-TORe method is a newer approach that has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: C. Roberto Simons-Linares, MD — The Cleveland Clinic
• Study coordinator: C. Roberto Simons-Linares, MD

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