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WULTER: Wireless Ultra Long-Term EEG Recordings in Epilepsy

Sponsor
UNEEG Medical A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05915988
Collaborator
(none)
19
Enrollment
1
Arm
26
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The present study is a 12 months pre-market open-label, prospective study for confirmation of the safety and performance 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.

Condition or Disease Intervention/Treatment Phase
  • Device: UNEEG EpiSight solution
 N/A

Detailed Description

The study is a multicentre study with up to 6 centres running in up to four countries. Each site will enrol 5-8 subjects with 4-7 completers of 40 days of recording. Enrolment of subjects to the study will be terminated after 19 subjects have reached 40 days of recording. The total recruitment period is ex-pected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last patient out).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the Subcutaneous UNEEG EpiSight Solution
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: open-label

UNEEG EpiSight solution

Device: UNEEG EpiSight solution
Implantation subcutis under local anesthetics

Outcome Measures

Primary Outcome Measures

  1. Usage of UNEEG EpiSight Recorder [up to a maximum of 12 months]

    Mean number of hours of use of UNEEG EpiSight Recorder per day (24h) throughout the investigational period

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients with uncontrolled epilepsy in which seizures are detectable in an area of the implant

  • Adults (above 18 years)

  • Intends to use the UNEEG EpiSight so-lution day and night (24/7)

  • 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 in-formed 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 implantable brain stimulation and external/transcranial brain stimulation

  • Infection at the site of device implantation

  • Contraindications to the local anaesthetic used during implantation and explantation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • UNEEG Medical A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UNEEG Medical A/S
ClinicalTrials.gov Identifier:
NCT05915988
Other Study ID Numbers:
  • UNEEG-U011
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Epilepsy

Study Results

No Results Posted as of Jun 23, 2023