Comparing Reduction With ESD- Versus APC-TORe

Launched by CARLOS ROBERTO SIMONS-LINARES · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to perform a procedure called Transoral Outlet Reduction (TORe), which helps with weight loss for individuals who have regained weight after undergoing Roux-en-Y gastric bypass surgery. The main goals of the trial are to find out which method leads to more weight loss and which one is safer for patients. If you are an adult who has had Roux-en-Y gastric bypass and have experienced weight regain, you might be eligible to participate.

Participants will receive one of the two variations of the TORe procedure, but all other care will be the same for both groups. This means that everyone will follow the same post-procedure care and dietary guidelines. The researchers will closely monitor and compare the results from both methods to determine which is more effective and safer for patients. It’s important to note that there are certain medical conditions that may exclude someone from participating, such as active infections or other gastrointestinal issues. If you're interested in learning more or if you think you might qualify, you can talk to your healthcare provider for further information.

Gender

ALL

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