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

Recruiting N/A Interventional Study
Focal Epilepsy Intraoperative Monitoring
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
12 (estimated)
Sponsor
Neurosoft Bioelectronics SA · Industry
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About This Trial
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 epileps…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 fo…
Contacts

Karolina Janikowska Clinical Affairs Manager, PhD

000 000-0000

karolina.janikowska@neurosoft-bio.com

CONTACT

G.J.M. Zijlmans Study Principal Investigator, PhD

000 000-0000

G.J.M.Zijlmans@umcutrecht.nl

CONTACT