WISE Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)
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|ClinicalTrials.gov Identifier: NCT03731455|
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : May 10, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Adult Epilepsy||Device: WISE Cortical Strip||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|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)|
|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|
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.
- Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip. [ Time Frame: 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 ]
- Impedance values measured for the WISE Cortical Strip. [ Time Frame: During the surgery ]
- Motor Evoked Potentials (MEPs). [ Time Frame: During the surgery ]
- Dedicated usability questionnaire. [ Time Frame: Following surgeries ]
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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|
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
|Klinikum der Universitat München|
|Munich, Germany, 81377|
|Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)|
|Verona, Italy, 37126|
|Bern, Switzerland, 3010|
|Luzern, Switzerland, 6000|
|Zürich, Switzerland, 8091|
|Responsible Party:||Wise S.r.l.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|