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WISE Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731455
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : May 10, 2021
Sponsor:
Collaborators:
Genae
Fondazione Don Carlo Gnocchi Onlus
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Tumor Adult Epilepsy Device: WISE Cortical Strip Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The neurosurgical intervention will be performed with both devices: investigational (Wise Cortical Strip, WCS) and comparator device.
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : April 9, 2019
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : January 20, 2020


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.




Primary Outcome Measures :
  1. Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip. [ Time Frame: For the entire duration of the surgeries and after 24 hours ]
  2. The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals. [ Time Frame: During the surgery ]

Secondary Outcome Measures :
  1. Impedance values measured for the WISE Cortical Strip. [ Time Frame: During the surgery ]
  2. Motor Evoked Potentials (MEPs). [ Time Frame: During the surgery ]
  3. Dedicated usability questionnaire. [ Time Frame: Following surgeries ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731455


Locations
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Germany
Klinikum der Universitat München
Munich, Germany, 81377
Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)
Verona, Italy, 37126
Switzerland
Inselspital
Bern, Switzerland, 3010
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Universitätsspital
Zürich, Switzerland, 8091
Sponsors and Collaborators
Wise S.r.l.
Genae
Fondazione Don Carlo Gnocchi Onlus
Publications:
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Responsible Party: Wise S.r.l.
ClinicalTrials.gov Identifier: NCT03731455    
Other Study ID Numbers: 001_WCS
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wise S.r.l.:
Cortical strip
Electrode