MagDI U.S. Registry

Overview

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.

Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896). Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Central Contacts