12
Participants
Start Date
January 1, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
March 31, 2026
SOFT ECoG subdural grid electrode
"Test Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection.~All procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marked device (CD). The investigational, non-CE marked device is not used for clinical decision making."
RECRUITING
University Medical Center (UMC) Utrecht, Utrecht
Lead Sponsor
UMC Utrecht
OTHER
European Research Council
OTHER
Neurosoft Bioelectronics SA
INDUSTRY