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ACTIVE NOT RECRUITING
NCT05915988
NA

U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

Sponsor: UNEEG Medical A/S

View on ClinicalTrials.gov

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

DEVICE

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