Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-19
Brief Title:
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery EpiGrid
Sponsor:
Neurosoft Bioelectronics SA
Organization:
Neurosoft Bioelectronics SA
Study Overview
Official Title:
The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EpiGrid
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None