Active — Not RecruitingNot Applicable

MagDI Italian Study

Italy60 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 range18 Years – 65 Years

SexALL

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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.

What they're measuring

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

Safety of the MagDI System

Timeframe: Procedure, Day 90, Day 180, Day 360

Trial details

NCT IDNCT06613711

SponsorGT Metabolic Solutions, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-17

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