NCT05915988

U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a multi-center study with 2-5 European sites in 2-4 countries. Each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. The total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	UNEEG EpiSight solution	Implantation subcutis under local anesthetics

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-06-23
• Last updated: 2025-11-28

Locations

5 sites across 2 countries: Denmark, Ireland