Wireless Ultra Long-Term EEG Recordings in Epilepsy - a Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
The present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of UNEEG EpiSight solution in subjects with uncontrolled epilepsy (indicated for EEG monitoring with the Implant) in which seizures are detectable in an area of the Implant. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.
• Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant
• Adults (above 18 years)
• Is willing and able to use the UNEEG EpiSight solution day and night for the duration of the study
• Subject is willing and able to provide written informed consent
• Subject is able to complete all study-required procedures, assessments and follow-up