Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

Inclusion Criteria: * 18 yrs of age or older and \< 65 yrs of age * At least 2 yrs post-Roux-En-Y gastric bypass surgery * Initially achieved at least 50% weight loss * At enrollment, has regain at least 15% of weight loss * BMI 40 or greater or 35 or greater with one or more co-morbidities * Stoma diameter at least 20 mm * Completes successful nutritional screening * Is a candidate for a surgical revision procedure * Is a reasonable risk to undergo general anesthesia * Completes successful cardiopulmonary evaluation * ASA Classification of less than or equal to III * Able to provide written consent * Able to return for protocol-specified evaluations Exclusion Criteria: * Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments * Previous bariatric revision procedure * Has another causal factor for weight regain other than stoma or pouch dilatation * Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program