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Clinical Trials in Ireland / NCT05915988
Active, not recruiting Not applicable

U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

NCT05915988 · tracked via the Priya Life Science Ireland tracker
Sponsor
UNEEG Medical A/S
Phase
Not applicable
Started
2023-12-04
Last updated
2025-11-28

Condition(s) studied

Epilepsy

Investigational drug(s) / intervention(s)

UNEEG EpiSight solution

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)

Trial sites (5)

FacilityCityRegionStatus
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.

View NCT05915988 on ClinicalTrials.gov ↗ ← All trials in Ireland