MagDI Canada Study

NCT06467955 | Active Not Recruiting

• 1 other identifier: GTM-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.

Conditions

Type 2 Diabetes; Obesity

Keywords

GT Metabolic; MagDI System; Magnetic Anastomosis

Outcome Measures

Primary Outcomes (2)

• Performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.

  The duodeno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnets (≥ 90% alignment of magnets) and * Passage of Magnets without surgical re-intervention; and * Creation of a patent anastomosis confirmed radiologically. The primary endpoint will be met if the performance is confirmed in ≥ 80% of enrolled and treated participants.

  From date of study index procedure through 90 days

• Safety of the MagDI System

  Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: * All-cause mortality * Intestinal perforation and/or peritonitis * Intestinal obstruction * Life-threatening bleeding * Incidence of device malfunctions

  From date of study index procedure through 360 days.

Study Arms (1)

Magnet System, DI Biofragmentable

EXPERIMENTAL

GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System)

Device: Magnet System, DI Biofragmentable

Interventions

Magnet System, DI Biofragmentable DEVICE

Anastomoses achieved by magnetic compression.

Magnet System, DI Biofragmentable

Eligibility Criteria

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

You may qualify if:

• Between 18-65 years of age, at the time of informed consent.
• Body Mass Index (BMI) between 30-50 kg/m2
• Meets one of the following criteria:
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
• Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.
• Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
• Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.

You may not qualify if:

• Type 1 diabetes.
• Use of injectable insulin.
• Uncontrolled Type 2 Diabetes Mellitus (T2DM).
• Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
• Uncontrolled hypertension, dyslipidemia or sleep apnea.
• Prior intestinal, colonic or duodenal surgery (other than bariatric).
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
• Refractory gastro-esophageal reflux disease (GERD).
• Barrett's disease.
• Helicobacter pylori positive and/or active ulcer disease.
• Large hiatal hernia.
• Inflammatory bowel or colonic diverticulitis disease.
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
• Implantable pacemaker or defibrillator.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (3)

University of Toronto

Toronto, Ontario, Canada

Location

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

Westmount Square Surgical Center

Westmount, Quebec, H3Z 2P9, Canada

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Model Details: Single arm, multi-center study enrolling up to 60 participants at up to 3 sites in Canada.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 21, 2024
• Study Start: May 10, 2024
• Primary Completion: January 27, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)