EpilepsyNCT05915988
U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy
A study testing UNEEG EpiSight solution in people with Epilepsy, run by UNEEG Medical A/S at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- UNEEG EpiSight solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Odense University Hospital
Odense, 5000
Regional Hospital of Viborg
Viborg, 8800
About this study
Official title: Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
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.
Read the detailed 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).
- Conditions
- Epilepsy
- Being tested
- UNEEG EpiSight solution
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNEEG EpiSight solutionDevice
Implantation subcutis under local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| open-label | Other | UNEEG EpiSight solution Receives: Device: UNEEG EpiSight solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of UNEEG EpiSight Recorder
Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording
Measured: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Secondary outcomes (2)
Device deficiencies
Nature and frequency of device deficiencies
Measured: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Adverse events
Nature and frequency of adverse events
Measured: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start4 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNEEG Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norman Delanty, Prof, Principal investigator, Beaumont Hospital, DublinDaniel Costello, Prof, Principal investigator, Cork University HospitalChristoph Beier, Prof, Principal investigator, Odense University HospitalLis Gregoretti Pluss, M.D., Principal investigator, Regional Hospital of ViborgKimmo Jensen, Prof, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915988
- Sponsor's protocol ID
- UNEEG-U011
- Status last verified
- Jan 2025
- First submitted
- 13 Jun 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
- ClinicalTrials.gov ID
- NCT05915988
- Acronym / sponsor ID
- UNEEG-U011
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label | Other | Device: UNEEG EpiSight solutionUNEEG EpiSight solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNEEG EpiSight solutionImplantation subcutis under local anesthetics | Device | open-label |
Primary outcome
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
2 secondary outcomes
Device deficiencies
Time frame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Adverse events
Time frame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Delanty, Prof principal investigator
Beaumont Hospital, Dublin
Daniel Costello, Prof principal investigator
Cork University Hospital
Christoph Beier, Prof principal investigator
Odense University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNEEG EpiSight solution in people with Epilepsy, run by UNEEG Medical A/S at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of UNEEG EpiSight Recorder (time frame: Throughout the run of the investigation (enrollment per subject is up to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.