NCT05049824CompletedNot Applicable
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
GI Windows, Inc.1 site in 1 country27 target enrollmentStarted: October 26, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Weight Loss
Study Overview
Brief Summary
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Weight Loss
Time Frame: 12 Months
1. Weight loss measured as a percent of total body weight (TBW)
Secondary Outcomes
- Change in blood pressure(12 Months)
- Change in Absolute Weight Loss(12 Months)
- Percent responders(12 Months)
- Change in BMI(12 Months)
- Change in HbA1c(12 Months)
- Change in serum lipids(12 Months)
- Excess weight loss(12 Months)
- Change in fasting glucose(12 Months)
Investigators
Study Sites (1)
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