MagDI U.S. Registry
Part of paid clinical trials in Ventura, California.
- Sponsor
- GT Metabolic Solutions, Inc.
- Study ID
- NCT06928545
- Status
- Recruiting
Conditions
- Anastomosis, Surgical
- Bowel Obstruction
- Internal Hernia
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Side-to-side duodenal-ileal anastomosis — DEVICESide-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Study Details
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
Key Dates
- Start date
- Mar 28, 2025
- Status verified
- Feb 2026
- Primary completion
- Mar 31, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 106 participants (estimated)
Arms
- Arm: MagDI SystemParticipants who underwent the MagDI System procedure and consented to participate in the Registry
Primary Outcome Measure
Incidence of Internal Hernia and Bowel Obstructions [ Time Frame: From date of study index procedure through 360 days. ]
Central Contacts
- Lisa Griffin Vincent, PhD, MA+1 763-200-1416
- Josh Schumacher+1 763-200-1416
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ventura Advanced Surgical Associates | Ventura | California | 93003 | Hellmuth Billy 805-676-9100 Helmuth Billy, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Healthcare System, Inc. | Louisville | Kentucky | 40299 | Candice Brunton John Oldham, MD (PRINCIPAL_INVESTIGATOR) |
| Ochsner Clinic Foundation | Lafayette | Louisiana | 70503 | Ashunti Pearson Philip Gachassin, MD (PRINCIPAL_INVESTIGATOR) |
| Bariatric Specialists of the Carolinas | Cary | North Carolina | 27518 | Jamie Lee Bull, PA Paul Enochs, MD (PRINCIPAL_INVESTIGATOR) |
| Transform Weight Loss | Lynnwood | Washington | 98036 | Josiah Billing Peter Billing, MD (PRINCIPAL_INVESTIGATOR) |
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