Wireless Ultra Long-Term EEG Recordings in Epilepsy

Study Overview
=================
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).

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

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: UNEEG EpiSight solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open-label<br>UNEEG EpiSight solution | Device: UNEEG EpiSight solution<br>* Implantation subcutis under local anesthetics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device deficiencies | Nature and frequency of device deficiencies | Throughout the run of the investigation (enrollment per subject is up to 12 months) | 
| Adverse events | Nature and frequency of adverse events | Throughout the run of the investigation (enrollment per subject is up to 12 months) |