Condition: Focal Epilepsy · Intraoperative Monitoring · Sponsor: Neurosoft Bioelectronics SA
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.
This description comes directly from the study's public registry record.
Karolina Janikowska Clinical Affairs Manager, PhD · 000 000-0000 · karolina.janikowska@neurosoft-bio.com
G.J.M. Zijlmans Study Principal Investigator, PhD · 000 000-0000 · G.J.M.Zijlmans@umcutrecht.nl
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| University Medical Center (UMC) Utrecht | Utrecht, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06205160