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Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

RecruitingNAAges 18 Years - anyAllNeurosoft Bioelectronics SA
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 Criteria: * 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.
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What it tests

  • SOFT ECoG subdural grid electrode
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Where

1 site
University Medical Center (UMC) Utrecht
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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