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

NCT04627103 | Completed DMC

• 1 other identifier: GIW 20-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Disease; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Weight loss measured as a percent of total body weight (TBW)

  12 months

Secondary Outcomes (13)

• Percent Responders

  12 months

• Excess Weight Loss Measures

  12 months

• Absolute Weight Loss Measures

  12 months

• BMI - Weight Loss Measures

  12 months

• Fasting Glucose

  12 months

Study Arms (1)

Device Placement

EXPERIMENTAL

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

Interventions

Self Forming Magnetic (SFM) Anastomosis System DEVICE

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.

Device Placement

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (2)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Université Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 13, 2020
• Study Start: October 7, 2021
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)