NCT06131281Recruiting
Comparing Reduction With ESD- Versus APC-TORe
Comparing Outcomes of Classic Transoral Outlet Reduction (TORe) Versus Endoscopic Submucosal Dissection-TORe: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 9 Nov 2023
- Start date
- 2 Oct 2023
- Primary completion date
- Apr 2028
- Lead sponsor
- Stephen Firkins
- Diseases
- Obesity
- NCT number
- NCT06131281
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 2 Oct 2023 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior revision of gastric bypass
- Participating in another ongoing clinical trial of an investigational weight loss drug or device
- Use of anticoagulation therapy or P2Y12 inhibitors which cannot be discontinued for the time frame surrounding the procedure
Other illness
- 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
- Insulin-dependent diabetes mellitus
Other
- Inability to undergo general anesthesia
- Active pregnancy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.