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

Study Overview
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Brief Summary
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Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Device: Self Forming Magnetic (SFM) Anastomosis System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SFM Treatment Arm<br>The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion | Device: Self Forming Magnetic (SFM) Anastomosis System<br>* The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | 1. Weight loss measured as a percent of total body weight (TBW) | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent responders | Percent of subjects losing at least 10% and 20% of baseline weight from baseline | 12 Months | 
| Excess weight loss | Mean change in Excess weight loss from baseline | 12 Months | 
| Change in serum lipids | Mean change in serum lipids from baseline | 12 Months | 
| Change in blood pressure | Mean change in blood pressure from baseline | 12 Months | 
| Change in fasting glucose | Mean change in fasting glucose in subjects with T2DM at baseline | 12 Months | 
| Change in HbA1c | Mean change in HbA1c in subjects with T2DM at baseline | 12 Months | 
| Change in BMI | Mean change in BMI from baseline | 12 Months | 
| Change in Absolute Weight Loss | Mean change in Absolute Weight Loss from baseline | 12 Months |