Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy

Inclusion Criteria: * Age 22-65 years at screening * Body mass index (BMI) ≥35 and ≤50 * Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain. * Weight stable over 3-month period * Negative H. pylori breath test * Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * Able to understand and sign informed consent documents. Exclusion Criteria: * Known or suspected allergy to nickel or titanium or nitinol * Contraindication to general anesthesia * Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series * Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * Clinically significant findings during screening endoscopy at target region for compression anastomosis * Uncontrolled hypertension * Pre-existing severe comorbid cardio-respiratory disease * History of type 1 diabetes or poorly controlled type 2 diabetes * Abnormal liver biochemistry * History of chronic gastrointestinal disease * Specific genetic or hormonal cause of obesity * Recent tobacco/nicotine product cessation (within 3 months prior)