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

This is an interventional treatment trial for Obesity, Morbid Read More

Inclusion Criteria:

1. Age 22-65 years at screening

2. 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.

   a. 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

3. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
4. Able to understand and sign informed consent document
5. Patient lives, and intends to remain, within a 300-km radius of study center for 24 months
6. Willing to refrain from smoking during the study follow-up period
7. 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

Exclusion Criteria:

1. Type 1 Diabetes
2. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
3. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
4. Contraindication to general anesthesia
5. 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
6. Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
7. Presence of a duodenal diverticulum (>10mm)
8. 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
9. 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
10. Uncontrolled severe hypertension (blood pressure >160/100mmHg)
11. 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)
12. Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
13. 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
14. Uncorrectable anemia (Hemoglobin < 11 g/dL in women and <12.5 g/dL in men)
15. Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome
16. For females of child-bearing potential: Pregnancy or desire to be pregnant during the study