Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Sponsor: Neurosoft Bioelectronics SA
Summary
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.
Official title: The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-01-01
Completion Date
2027-03
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
University Medical Center (UMC) Utrecht
Utrecht, Netherlands