Wireless Ultra Long-Term EEG Recordings in Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915988
• Other study ID #: UNEEG-U011
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: UNEEG Medical A/S
• Contact: Rikke Boege, BCs
• Phone: +45 2712 9303
• Email: studies[@]uneeg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• UNEEG EpiSight solution
Implantation subcutis under local anesthetics

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
UNEEG Medical A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance	Number of recording hours by UNEEG EpiSight solution per day (24 hours) throughout the study period	Throughout the run of the investigation (enrollment per subject is up to 12 months)
Primary	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	Device deficiencies	Nature and frequency of device deficiencies	Throughout the run of the investigation (enrollment per subject is up to 12 months)
Secondary	Adverse events	Nature and frequency of adverse events	Throughout the run of the investigation (enrollment per subject is up to 12 months)