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NCT Number: NCT05915988

U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

UNEEG EpiSight solution

Device

Implantation subcutis under local anesthetics

Primary outcomes

  1. Usage of UNEEG EpiSight Recorder

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

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

Secondary outcomes

  1. Device deficiencies

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

    Nature and frequency of device deficiencies

  2. Adverse events

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

    Nature and frequency of adverse events

Other outcomes

  1. Performance

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

    Number of recording hours by UNEEG EpiSight solution per day (24 hours) throughout the study period

Sponsors and collaborators

Lead sponsor

UNEEG Medical A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 23, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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