U.S., Sept. 17 -- ClinicalTrials.gov registry received information related to the study (NCT07823465) titled 'RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study' on Sept. 11.
Brief Summary: The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents aged 12 through 17 who have already received the device in routine clinical practice. Data will come from patient-authorized electronic health records and patient-reported outcomes collected through a central study site, not a traditional trial infrastructure.
Up to 100 evaluable patients across the...