Epilepsy
Conditions
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.
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).
Interventions
DEVICEUNEEG EpiSight solution
Implantation subcutis under local anesthetics
Sponsors
UNEEG Medical A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of UNEEG EpiSight Recorder | 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
| Measure | Time frame | Description |
|---|---|---|
| Device deficiencies | Throughout the run of the investigation (enrollment per subject is up to 12 months) | Nature and frequency of device deficiencies |
| Adverse events | Throughout the run of the investigation (enrollment per subject is up to 12 months) | Nature and frequency of adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Performance | 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 |
Countries
Denmark, Ireland
Outcome results
None listed