Post-Market Study of Internal Hernia and Bowel Obstruction One Year After Using the MagDI System for Side-to-Side Duodeno-Ileal Magnetic Compression Anastomosis in U.S. Patients

What this Trial Is About

Researchers are studying the incidence and severity of internal hernia and bowel obstruction within one year after using the MagDI System to create side-to-side duodeno-ileal anastomoses in a U.S. population. This observational registry study compares data from patients treated with the MagDI System in the U.S. to previous premarket clinical study results and existing scientific literature. The research focuses on these post-surgical complications, which can occur after abdominal surgeries, including bariatric surgery. Participants in this study have undergone the MagDI System procedure, which uses magnetic compression to form a side-to-side connection between the duodenum and ileum. The study collects data from patients treated at U.S. registry centers. The registry is a post-market surveillance effort required by the FDA following the systems clearance. Participants consent to be followed in this observational registry to monitor outcomes. During the study, researchers will track the occurrence and severity of internal hernias and bowel obstructions for up to 360 days after the index procedure. There are no assigned treatments or interventions beyond the standard MagDI System procedure. Data will be collected through patient follow-up and clinical records to assess these outcomes. The study will continue until April 2027, involving regular monitoring of participant health related to the surgical procedure.

MagDI U.S. Registry