Actively Recruiting
MagDI Canada Study
Led by GT Metabolic Solutions, Inc. · Updated on 2025-12-23
60
Participants Needed
3
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MagDI Canada Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years of age at the time of informed consent
- Body Mass Index (BMI) between 30 and 50 kg/m2
- Has type 2 diabetes mellitus (HbA1c 6.5%) or weight regain following previous sleeve gastrectomy (at least 12 months ago)
- Has type 2 diabetes mellitus (HbA1c 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (at least 12 months ago)
- Has type 2 diabetes mellitus (HbA1c 6.5%) with BMI between 30 and 35 without previous sleeve gastrectomy and no plan to perform concurrent sleeve gastrectomy
- Agrees to avoid any additional bariatric or reconstructive surgery affecting body weight during the study
- Has been informed about the study, agrees to follow testing, medications, follow-up visits, and provides written informed consent
You will not qualify if you...
- Has type 1 diabetes
- Uses injectable insulin
- Has uncontrolled type 2 diabetes mellitus
- Planned sleeve gastrectomy with duodeno-ileal anastomosis procedure
- Has uncontrolled hypertension, dyslipidemia, or sleep apnea
- Previous intestinal, colonic, or duodenal surgery (except bariatric)
- Has surgery, trauma, prostheses, disease, or genetic conditions preventing the procedure
- Has refractory gastro-esophageal reflux disease (GERD)
- Has Barrett's disease
- Positive for Helicobacter pylori and/or active ulcer disease
- Has large hiatal hernia
- Has inflammatory bowel or colonic diverticulitis disease
- Has anomalies preventing or contraindicating orogastric, endoscopic, or laparoscopic access
- Has implantable pacemaker or defibrillator
- Has psychiatric disorder except well-controlled depression with medication for over 6 months
- History of substance abuse
- Is pregnant, lactating, or planning pregnancy during the study and females must agree to use safe contraception
- Has comorbidities or fitness status making the participant medically unfit for the procedure
- Has unhealed ulcers, bleeding lesions, tumors, or lesions at magnet placement site
- Expected to need MRI within first 2 months post-procedure
- Has surgical or interventional procedure within 30 days before or after study procedure
- Stroke or Transient Ischemic Attack within 6 months prior to consent
- Requires chronic anticoagulation therapy except aspirin
- Has active infections requiring antibiotics unless resolved before procedure
- Recent tobacco or nicotine cessation within 3 months prior to consent
- Known allergies to device components or contrast media
- Comorbidities likely to limit life expectancy to 12 months
- Currently participating in investigational drug or device study not completed primary endpoint
- Positive COVID-19 test prior to study procedure per local protocol
- Has other anatomic, medical, social or psychological conditions limiting ability to participate or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Toronto
Toronto, Ontario, Canada
Not Yet Recruiting
2
McGill University
Montreal, Quebec, Canada, H3A 0G4
Not Yet Recruiting
3
Westmount Square Surgical Center
Westmount, Quebec, Canada, H3Z 2P9
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD
CONTACT
J
Josh Schumacher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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