WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

Not Applicable

Completed

• Conditions: Epilepsy; Brain Tumor Adult
• Interventions: Device: WISE Cortical Strip

• Registration Number: NCT03731455
• Lead Sponsor: Wise S.r.l.

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 and/or 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 (e.g. 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 brain's 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 Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Study Start: 2019-04-09
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational and Comparator devices	WISE Cortical Strip	Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together.

Primary Outcome Measures

Name	Time	Method
Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.	For the entire duration of the surgeries and after 24 hours
The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals.	During the surgery

Secondary Outcome Measures

Name	Time	Method
Motor Evoked Potentials (MEPs).	During the surgery
Impedance values measured for the WISE Cortical Strip.	During the surgery
Dedicated usability questionnaire.	Following surgeries

Trial Locations

Locations (5)

Klinikum der Universitat München; 🇩🇪 Munich, Germany

Universitätsspital; 🇨🇭 Zürich, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona); 🇮🇹 Verona, Italy