Status:
RECRUITING
Comparing Reduction With ESD- Versus APC-TORe
Lead Sponsor:
Stephen Firkins
Conditions:
Obesity
Roux-en-y Anastomosis Site
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 weigh...
Detailed Description
Weight regain after having a Roux-en-Y gastric bypass is common. One of the primary reasons for weight regain after bypass is stretching out or "dilation" of the surgical connection created between wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06131281
Start Date
October 2 2023
End Date
April 1 2026
Last Update
November 7 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195