U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

Last updated: January 7, 2025
Sponsor: UNEEG Medical A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

UNEEG EpiSight solution

Clinical Study ID

NCT05915988
UNEEG-U011
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with uncontrolled epilepsy in which seizures are detectable in an areacovered by the implant

  • Adults (above 18 years)

  • Is willing and able to use the UNEEG EpiSight solution day and night for theduration 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

Exclusion Criteria:

  • Vulnerable subjects, including severe cognitive impairment precluding informedconsent

  • Cannot or do not have the necessary assistance, to properly operate the system

  • High risk of surgical complications, such as active systemic infection andhaemorrhagic disease

  • Involved in therapies with medical devices that deliver electrical energy into thearea around the implant, such as cochlear implant(s), implantable brain stimulationand external/transcranial brain stimulation

  • Contraindications to the local anaesthetic used during implantation and explantation

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: UNEEG EpiSight solution
Phase:
Study Start date:
December 04, 2023
Estimated Completion Date:
December 31, 2026

Study 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).

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • Regional Hospital of Viborg

    Viborg, 8800
    Denmark

    Active - Recruiting

  • Cork University Hospital

    Cork,
    Ireland

    Active - Recruiting

  • Beaumont Hospital

    Dublin, 9
    Ireland

    Active - Recruiting

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