NCT05915988

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

June 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

June 13, 2023

Last Update Submit

November 21, 2025

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Usage of UNEEG EpiSight Recorder

    Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording

    Throughout the run of the investigation (enrollment per subject is up to 12 months)

Secondary Outcomes (2)

  • Device deficiencies

    Throughout the run of the investigation (enrollment per subject is up to 12 months)

  • Adverse events

    Throughout the run of the investigation (enrollment per subject is up to 12 months)

Other Outcomes (1)

  • Performance

    Throughout the run of the investigation (enrollment per subject is up to 12 months)

Study Arms (1)

open-label

OTHER

UNEEG EpiSight solution

Device: UNEEG EpiSight solution

Interventions

UNEEG EpiSight solutionDEVICE

Implantation subcutis under local anesthetics

open-label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant
  • Adults (above 18 years)
  • Is willing and able to use the UNEEG EpiSight solution day and night for the duration 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

You may not qualify if:

  • Vulnerable subjects, including severe cognitive impairment precluding informed consent
  • Cannot or do not have the necessary assistance, to properly operate the system
  • High risk of surgical complications, such as active systemic infection and haemorrhagic disease
  • Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation
  • Contraindications to the local anaesthetic used during implantation and explantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Regional Hospital of Viborg

Viborg, 8800, Denmark

Location

Cork University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Norman Delanty, Prof

    Beaumont Hospital, Dublin

    PRINCIPAL INVESTIGATOR

  • Daniel Costello, Prof

    Cork University Hospital

    PRINCIPAL INVESTIGATOR

  • Christoph Beier, Prof

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Lis Gregoretti Pluss, M.D.

    Regional Hospital of Viborg

    PRINCIPAL INVESTIGATOR

  • Kimmo Jensen, Prof

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 23, 2023

Study Start

December 4, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)IE(2)