UNEEG EpiSight solution: Implantation subcutis under local anesthetics
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* Vulnerable subjects, including severe cognitive impairment precluding informed consent
* Cannot or do not have the necessary assistance, to properly operate the system
* High risk of surgical complications, such as active systemic infection and haemorrhagic disease
* Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation
* Contraindications to the local anaesthetic used during implantation and explantation
Primary outcome measure(s)
Usage of UNEEG EpiSight Recorder — Throughout the run of the investigation (enrollment per subject is up to 12 months) Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording
Trial sites (5)
Facility
City
Region
Status
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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