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Wireless Ultra Long-Term EEG Recordings in Epilepsy

Primary Purpose

Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UNEEG EpiSight solution
Sponsored by
UNEEG Medical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    open-label

    Arm Description

    UNEEG EpiSight solution

    Outcomes

    Primary Outcome Measures

    Usage of UNEEG EpiSight Recorder
    Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording

    Secondary Outcome Measures

    Device deficiencies
    Nature and frequency of device deficiencies
    Adverse events
    Nature and frequency of adverse events

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    August 11, 2023
    Sponsor
    UNEEG Medical A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05915988
    Brief Title
    Wireless Ultra Long-Term EEG Recordings in Epilepsy
    Official Title
    Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UNEEG Medical A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    open-label
    Arm Type
    Other
    Arm Description
    UNEEG EpiSight solution
    Intervention Type
    Device
    Intervention Name(s)
    UNEEG EpiSight solution
    Intervention Description
    Implantation subcutis under local anesthetics
    Primary Outcome Measure Information:
    Title
    Usage of UNEEG EpiSight Recorder
    Description
    Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording
    Time Frame
    Throughout the run of the investigation (enrollment per subject is up to 12 months)
    Secondary Outcome Measure Information:
    Title
    Device deficiencies
    Description
    Nature and frequency of device deficiencies
    Time Frame
    Throughout the run of the investigation (enrollment per subject is up to 12 months)
    Title
    Adverse events
    Description
    Nature and frequency of adverse events
    Time Frame
    Throughout the run of the investigation (enrollment per subject is up to 12 months)
    Other Pre-specified Outcome Measures:
    Title
    Performance
    Description
    Number of recording hours by UNEEG EpiSight solution per day (24 hours) throughout the study period
    Time Frame
    Throughout the run of the investigation (enrollment per subject is up to 12 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofie Sylvest Nielsen, PhD
    Phone
    +45 4063 8000
    Email
    studies@uneeg.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Norman Delanty, Prof
    Organizational Affiliation
    Beaumont Hospital, Dublin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Wireless Ultra Long-Term EEG Recordings in Epilepsy

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