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