Status:
RECRUITING
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Lead Sponsor:
Neurosoft Bioelectronics SA
Collaborating Sponsors:
UMC Utrecht
European Research Council
Conditions:
Focal Epilepsy
Intraoperative Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured ...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of enrolment
- Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
- Provided informed consent for study participation by the subject
Exclusion
- Occipital lesion
- Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
- Planned ioECoG recordings during fully awake surgery and/or functional recordings
- Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
- Active participation in another investigational device study
- Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
- Insufficient understanding of Dutch language.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06205160
Start Date
January 1 2025
End Date
March 1 2027
Last Update
December 10 2025
Active Locations (1)
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1
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584CX