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 range18 Years – 65 Years
SexALL
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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.
✓. 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.
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
. 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.