- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731455
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)
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)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Munich, Germany, 81377
- Klinikum der Universität München
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Verona, Italy, 37126
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)
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Bern, Switzerland, 3010
- Inselspital
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Luzern, Switzerland, 6000
- Luzerner Kantonsspital
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Zürich, Switzerland, 8091
- Universitätsspital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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The WISE Cortical Strip is a medical device composed by a strip and by a cable.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.
Time Frame: For the entire duration of the surgeries and after 24 hours
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For the entire duration of the surgeries and after 24 hours
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The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals.
Time Frame: During the surgery
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During the surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Impedance values measured for the WISE Cortical Strip.
Time Frame: During the surgery
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During the surgery
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Motor Evoked Potentials (MEPs).
Time Frame: During the surgery
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During the surgery
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Dedicated usability questionnaire.
Time Frame: Following surgeries
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Following surgeries
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Fedele T, Schonenberger C, Curio G, Serra C, Krayenbuhl N, Sarnthein J. Intraoperative subdural low-noise EEG recording of the high frequency oscillation in the somatosensory evoked potential. Clin Neurophysiol. 2017 Oct;128(10):1851-1857. doi: 10.1016/j.clinph.2017.07.400. Epub 2017 Jul 27.
- Kim SM, Kim SH, Seo DW, Lee KW. Intraoperative neurophysiologic monitoring: basic principles and recent update. J Korean Med Sci. 2013 Sep;28(9):1261-9. doi: 10.3346/jkms.2013.28.9.1261. Epub 2013 Aug 28.
- Macdonald DB. Intraoperative motor evoked potential monitoring: overview and update. J Clin Monit Comput. 2006 Oct;20(5):347-77. doi: 10.1007/s10877-006-9033-0. Epub 2006 Jul 11.
- Aungaroon G, Zea Vera A, Horn PS, Byars AW, Greiner HM, Tenney JR, Arthur TM, Crone NE, Holland KD, Mangano FT, Arya R. After-discharges and seizures during pediatric extra-operative electrical cortical stimulation functional brain mapping: Incidence, thresholds, and determinants. Clin Neurophysiol. 2017 Oct;128(10):2078-2086. doi: 10.1016/j.clinph.2017.06.259. Epub 2017 Jul 18.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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