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U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy
Sponsor: UNEEG Medical A/S
Summary
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.
Official title: Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2023-12-04
Completion Date
2026-12
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
UNEEG EpiSight solution
Implantation subcutis under local anesthetics
Locations (5)
Aalborg University Hospital
Aalborg, Denmark
Odense University Hospital
Odense, Denmark
Regional Hospital of Viborg
Viborg, Denmark
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland