MagDI U.S. Registry
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.
| Condition(s) | Anastomosis, Surgical, Internal Hernia, Bowel Obstruction |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. \>21 years of age, at the time of informed consent. 2. Body Mass Index (BMI) between 30-50 kg/m2. 3. Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center. 4. Participant has been informed of the nature of the registry. Exclusion Criteria: 1\. Participant does not provide informed consent to be enrolled and followed in the registry. |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | GT Metabolic Solutions, Inc. |
| Locations | Ventura, California, United States; Louisville, Kentucky, United States; Lafayette, Louisiana, United States; Cary, North Carolina, United States; Lynnwood, Washington, United States |
| Start date | 2025-03-28 |
| NCT ID | NCT06928545 |
| Official listing | https://clinicaltrials.gov/study/NCT06928545 |