Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03731455
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2018-10-30
Brief Title:
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
Sponsor:
Wise Srl
Organization:
Wise Srl
Study Overview
Official Title:
A Prospective Interventional Multi-center Open-label Premarket Study to Evaluate Safety Performance and Usability of the Wise Cortical Strip for Intraoperative Neurophysiological Monitoring WIN Study
Status:
COMPLETED
Status Verified Date:
2021-05
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:
WIN
Brief Summary:
The WIN Study is a prospective interventional multi-center open-label premarket study designed to confirm the safety performance and intended use of the WISE Cortical Strip WCS for CE certification purposes Participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery who meet all eligibility criteria will undergo IntraOperative Neurophysiological Monitoring IONM during a neurosurgical intervention with the WCS and a comparator device
Detailed Description:
The IONM is the use of electrophysiological methods to identify important neural structures in the operative field including eloquent areas in order to monitor their functional integrity during the neurosurgical lesion resection The benefit of performing functional monitoring of the areas surrounding the lesion is to minimize neurological damages during surgical lesions resection and thus to avoid andor limit significant post-operative impairments During the therapeutic resection of brain tumors or epileptogenic lesions the use of the IONM is associated to other intraoperative techniques eg brain mapping techniques that together to combined efforts of a multidisciplinary team of neurosurgeons neuroradiologists neuropsychologists and neurophysiologists contribute to the definition of location extension and extent of functional involvement that a lesion causes in an individual participant
The principal electrophysiological methods to perform the IONM are the recording of brains electrical activities Somatosensory Evoked Potentials SEPs and ElectroCorticoGraphy ECoG and electrical stimulation of motor regions to elicit Motor Evoked Potentials MEPs using cortical strips placed on surface of the brain
Thus the WCS is intended to be used intraoperatively on the brain surface to perform brain monitoring
The principal electrophysiological methods to perform the IONM are the recording of brains electrical activities Somatosensory Evoked Potentials SEPs and ElectroCorticoGraphy ECoG and electrical stimulation of motor regions to elicit Motor Evoked Potentials MEPs using cortical strips placed on surface of the brain
Thus the WCS is intended to be used intraoperatively on the brain surface to perform brain monitoring
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