MagDI Italian Study (NCT06613711) | Clinical Trial Compass
CompletedNot Applicable
MagDI Italian Study
Italy27 participantsStarted 2024-09-20
Plain-language summary
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy 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 (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
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
. 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 trial tested a device called the MagDI System to create a surgical connection that diverts part of the digestive tract — how does that procedure compare to other surgeries for obesity and Type 2 diabetes that I might already be a candidate for?
2Since this trial is already completed, has my doctor seen any of the results on how safe and feasible the MagDI System was, and what do those findings mean for my situation?
3The trial was listed as 'Phase NA,' which often means it was focused on testing the device itself rather than proving long-term benefit — does that mean there's still limited evidence on whether this approach actually improves blood sugar control or weight loss over time?
4Because the study was done in Italy and is now complete, is the MagDI System available or approved anywhere yet, and would participating in or accessing it even be a realistic option for me?
5Given that this procedure involves creating a new surgical connection inside the digestive tract, what are the specific risks my doctor would want me to understand before considering any duodeno-ileal diversion approach like this one?
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
Feasibility and 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