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

NARecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Focal EpilepsyIntraoperative Monitoring
Interventions
DEVICE

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."

Trial Locations (1)

3584CX

RECRUITING

University Medical Center (UMC) Utrecht, Utrecht

Sponsors
All Listed Sponsors
collaborator

UMC Utrecht

OTHER

collaborator

European Research Council

OTHER

lead

Neurosoft Bioelectronics SA

INDUSTRY

NCT06205160 - Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid ) | Biotech Hunter | Biotech Hunter