Actively Recruiting
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Led by Neurosoft Bioelectronics SA · Updated on 2025-12-10
12
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
N
Neurosoft Bioelectronics SA
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery. Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
CONDITIONS
Official Title
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment
- Diagnosed with lesional epilepsy, including secondary mesial temporal sclerosis, suitable for intraoperative high-density grid recordings
- Provided informed consent to participate in the study
You will not qualify if you...
- Presence of an occipital lesion
- Surgeries involving a primary mesial temporal lesion, disconnection, or hemispherectomy
- Planned intraoperative ECoG recordings during fully awake surgery or functional recordings
- Use of anticoagulants that cannot be stopped during the perioperative period or having factor XIII deficiency or other blood disorders
- Current participation in another investigational device study
- Any condition that may affect safety or ability to complete the study as judged by the investigator
- Insufficient understanding of the Dutch language
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
K
Karolina Janikowska Clinical Affairs Manager, PhD
CONTACT
G
G.J.M. Zijlmans Study Principal Investigator, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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