U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subcutaneous EEG in Epilepsy

NCT02946151

Temporal Lobe Epilepsy

COMPLETED NA

Pediatric EEG Monitoring

NCT04664608

Pediatric ALL Epilepsy

COMPLETED

Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies

NCT06855901

Epilepsies Epilepsies, Focal Epileptic Encephalopathy

RECRUITING NA

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.

NCT04526418

Epilepsy

TERMINATED NA

A Wireless EEG Patch for Continuous Electrographic Monitoring

NCT03583957

Epilepsy

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open-label

UNEEG EpiSight solution

Group Type OTHER

UNEEG EpiSight solution

Intervention Type DEVICE

Implantation subcutis under local anesthetics

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UNEEG EpiSight solution

Implantation subcutis under local anesthetics

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No