Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GI Windows, Inc.
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.
Age
19–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
