WISE Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)

July 14, 2025 updated by: Wise S.r.l.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Klinikum der Universität München
  • Italy
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital
      • Zürich, Switzerland, 8091
        • Universitätsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Brain tumor or epilepsy that require neurosurgical intervention and exposure of the central region of the cerebral cortex including at least the hand-forearm areas in the primary motor cortex and the primary somatosensory cortex (i.e. excision of lesion, open approach)
  2. Age: 18 - 75 years at the time of enrollment
  3. Required intraoperative neurophysiological monitoring with subdural electrodes
  4. Willingness to provide informed consent for participating in the study

Exclusion critria:

  1. Significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol
  2. Acute or untreated infections (viral, bacterial or fungal)
  3. Currently on any anticoagulant medication that cannot be discontinued during the perioperative period, or patients with factor XIII deficiency or any other hematological disease
  4. Current treatment with antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational and Comparator devices
Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together.
Device: WISE Cortical Strip
The WISE Cortical Strip is a medical device composed by a strip and by a cable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.
Time Frame: For the entire duration of the surgeries and after 24 hours
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.
Time Frame: During the surgery
During the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Impedance values measured for the WISE Cortical Strip.
Time Frame: During the surgery
During the surgery
Motor Evoked Potentials (MEPs).
Time Frame: During the surgery
During the surgery
Dedicated usability questionnaire.
Time Frame: Following surgeries
Following surgeries

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wise S.r.l.

Collaborators

Fondazione Don Carlo Gnocchi Onlus
Genae

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2019

Primary Completion (Actual)

January 20, 2020

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 3, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 001_WCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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