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

Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or 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)