Wireless Ultra Long-Term EEG Recordings in Epilepsy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT05915988
Study type	Interventional
Source	UNEEG Medical A/S
Contact	Rikke Boege, BCs
Phone	+45 2712 9303
Email	studies@uneeg.com
Status	Recruiting
Phase	N/A
Start date	December 4, 2023
Completion date	December 2025

View Details

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