NCT05915988Active, not recruiting
U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy
Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 19 (estimated)
- First submitted
- 13 Jun 2023
- Start date
- 4 Dec 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- UNEEG Medical A/S
- Diseases
- Epilepsy
- NCT number
- NCT05915988
What you commit to
- Study type: Interventional
- Planned participants: 19
- From 4 Dec 2023 to the primary completion date, Dec 2025
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Vulnerable subjects, including severe cognitive impairment precluding informed consent
- High risk of surgical complications, such as active systemic infection and haemorrhagic disease
Other
- Cannot or do not have the necessary assistance, to properly operate the system
- Contraindications to the local anaesthetic used during implantation and explantation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Regional Hospital of Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Unknown status |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.