Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve

Prior treatment

• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy for SNAP-PS cohort), pancreas or right colon
• Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heart failure, uncontrolled cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease requiring supplemental oxygen, pulmonary embolism, MI with prior 6 months)

Other illness

• Type 1 Diabetes
• Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
• History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatory bowel disease) that in the opinion of the Investigator may preclude safe and complete study participation
• Uncontrolled severe hypertension (blood pressure \>160/100mmHg)
• Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome

Lab values

• Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c \>10 or use of injectable insulin
• Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
• Uncorrectable coagulation disorder (platelets \< 100,000, PT \>2 seconds above control or INR \>1.5) at time of procedure, Note: management of anti-platelet medications, when applicable, will follow standard practices of the institution
• Uncorrectable anemia (Hemoglobin \< 11 g/dL in women and \<12.5 g/dL in men)

Other

• Contraindication to general anesthesia
• Presence of a duodenal diverticulum (\>10mm)
• For females of child-bearing potential: Pregnancy or desire to be pregnant during the study

• Age 22-65 years at screening
• Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 with at least one obesity related comorbidity or ≥ 40 but ≤ 50 kg/m2 with or without comorbidities at time of screening.
  • For SNAP-PS Cohort, subject should be at least 18 months from the initial sleeve gastrectomy and have failed to achieve at minimum 50% EWL
• If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
• Able to understand and sign informed consent document
• Patient lives, and intends to remain, within a 300-km radius of study center for 24 months
• Willing to refrain from smoking during the study follow-up period
• If subject is female, she must commit to not becoming pregnant for 24 months and agree to use of contraceptives during this period and may not be nursing