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U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

NCT05915988 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-11-28

No results posted yet for this 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.

Conditions

Interventions

DEVICE

UNEEG EpiSight solution

Implantation subcutis under local anesthetics

Sponsors & Collaborators

  • UNEEG Medical A/S

    lead INDUSTRY

Principal Investigators

  • Norman Delanty, Prof · Beaumont Hospital, Dublin

  • Daniel Costello, Prof · Cork University Hospital

  • Christoph Beier, Prof · Odense University Hospital

  • Lis Gregoretti Pluss, M.D. · Regional Hospital of Viborg

  • Kimmo Jensen, Prof · Aalborg University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Denmark
  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05915988 on ClinicalTrials.gov