Outcome Measures
SAEs, bleeding, intra-abdominal hematoma
INTRA-ABDOMINAL HEMATOMA, BLEEDING, INTESTINAL PERFORATION
The primary endpoint was device feasibility at 30 days confirmed by (1) successful technical placement of the MS magnets, (2) expulsion of magnets without device-related AEs requiring surgical reintervention, and (3) creation of a patent duodeno-ileal anastomosis confirmed fluoroscopically and endoscopically. The endpoint was considered met if device performance was confirmed in ≥ 80% of patients. The primary safety endpoint was 30-day incidence of device- and procedure-related AEs (e.g., intra-abdominal hematoma) and SAEs (e.g., SAEs requiring intervention, e.g., intestinal perforation or obstruction, life-threatening bleeding) using the Clavien-Dindo classification [Secondary endpoints were ongoing safety and MBS efficacy measures of change in weight, HbA1