Study Design and Endpoints
The currently reported prospective observational study represents the first stage of a two-part single-arm open-label evaluation of the investigational MS (“The Magnet Study,” Clinicaltrials.gov NCT#05322122). The focus of stage one was small cohort evaluation of MS technical feasibility and safety at 30 days in a single center, as well as ongoing safety and preliminary MBS efficacy through 360 days.