Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Self Forming Magnetic (SFM) Anastomosis System

Detailed Description

Multi-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 with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Sciences Centre
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 19-65 years at screening
• Body mass index (BMI) ≥35 and ≤50
• T2DM diagnosis ≥6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but < 10.0% at time of enrollment.
• HbA1c must be stable over a 3-month period.
• Weight stable over 3-month period
• Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
• 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
• Type 1 diabetes or poorly controlled type 2 diabetes
• Use of injectable insulin
• Any documented conditions for which endoscopy would be contraindicated
• Contraindication to general anesthesia
• History of chronic gastrointestinal disease
• Congenial or acquired anomalies of the GI tract
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
• Uncontrolled hypertension
• Pre-existing severe comorbid cardio-respiratory disease
• History of chronic gastrointestinal disease
• Specific genetic or hormonal cause of obesity
• Recent tobacco/nicotine product cessation (within 3 months prior)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device Placement; The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed.

Device: Self Forming Magnetic (SFM) Anastomosis System; 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 Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	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 responders; i.e. percent of subjects losing at least 10% TBW	12 months
Excess Weight Loss Measures	Excess weight loss (EWL)	12 months
Absolute Weight Loss Measures	Absolute weight loss	12 months
BMI - Weight Loss Measures	Change in BMI	12 months
Fasting Glucose	Mean change in fasting glucose	12 months
Hemoglobin A1c	Mean change in Hemoglobin A1c	12 months
Diabetes Remission and/or Improvements	Proportion of subjects experiencing diabetes remission and/or improvements	12 months
Diabetes Medication Dosage and Frequency Changes	Mean change in the dosage and frequency of diabetes medications from baseline	12 months
Serum Lipids	Mean change in serum lipids	12 months
Blood Pressure Changes	Mean percent change in systolic/diastolic blood pressure	12 months
Liver Changes using Fibroscan	Change in Controlled Attenuation Parameter (CAP) Scores from baseline	12 months
Nutritional Status	Nutritional Status: changes in pre-albumin levels	12 months
Albumin - Nutritional Status	Nutritional Status: changes in albumin levels	12 months

Collaborators and Investigators

• Sponsor: GI Windows, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Disease; Sleeve Gastrectomy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus; Metabolic Diseases
• Other Study ID Numbers: GIW 20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No