MagDI Canada Study (NCT06467955) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MagDI Canada Study
Canada60 participantsStarted 2024-05-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is testing a surgical device called the MagDI System that creates a bypass between the duodenum and ileum — how does that procedure compare to other surgical or non-surgical options I might have for managing my obesity and type 2 diabetes?
2Since the trial is listed as 'active not recruiting,' does that mean I can no longer join, and if so, are there similar studies or procedures I could still be considered for?
3The trial is measuring the safety of the MagDI System as a primary goal, which suggests this is an early-stage evaluation — what does that mean for how much is already known about the risks of this specific device compared to more established bariatric surgeries?
4The procedure involves creating a new connection between two parts of the digestive tract — what are the potential complications of that kind of anastomosis, and how would any problems be treated if they occurred?
5Given that this trial focuses on a device-based surgical approach, would my doctor recommend I try other treatments like medication or lifestyle programs first before considering something like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
Timeframe: From date of study index procedure through 90 days
2
Safety of the MagDI System
Timeframe: From date of study index procedure through 360 days.
. 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.
Exclusion criteria
. 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.