MagDI Australia Study (NCT06473831) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MagDI Australia Study
Australia25 participantsStarted 2024-08-13
Plain-language summary
The objective of the MagDI Australia 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
. 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%) following previous sleeve gastrectomy (≥ 12 months); OR
. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy.
. Weight regain following previous sleeve gastrectomy (≥ 12 months).
. Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
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 is testing whether the MagDI System — a device that creates a surgical shortcut in the digestive tract to bypass part of the small intestine — is even feasible and safe to perform; so since it's still in the early feasibility and safety stage, what is actually known so far about how well it works for obesity or type 2 diabetes, and how does that compare to established surgical options like gastric bypass or sleeve gastrectomy?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new participants — does that affect whether this approach could be relevant to my situation now, and is there a follow-up study or next phase I should be watching for?
3Since the MagDI System creates a duodeno-ileal diversion using a magnetic device rather than traditional surgery, what specific risks are associated with having a permanent or semi-permanent device placed inside the digestive tract, and how would complications be managed if something went wrong?
4Before considering any experimental device like this, would you recommend I first try or complete standard treatments — such as medication for type 2 diabetes or medically supervised weight loss — and how would those outcomes affect whether a surgical option might even be appropriate for me?
5If this device or procedure doesn't work as hoped, would it be reversible or removable, and what would my options be if I needed to go back to a more conventional treatment path?
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
. 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.