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

NCT ID: NCT04627103

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2025-10-30

Brief Summary

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

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)

Conditions

Obesity; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self Forming Magnetic (SFM) Anastomosis System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GI Windows, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Université Laval

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

GIW 20-001

Identifier Type: -

Identifier Source: org_study_id