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 : January 27, 2020
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 (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation, Racine, Wisconsin, USA).
The WCS is a single use medical device intended for intraoperative use on the surface of the brain for stimulating the brain or recording the brain's electrical activity. This supports brain monitoring during resection of brain tumors or epileptogenic lesions.
In the WIN Study 28 adult participants will be enrolled in up to 5 investigational sites in Europe. The enrollment is expected to take 6 months per site. Subject participation will last from the date of signing of the informed consent until patient discharge within 7 days post-intervention ("discharge visit") or 7 days post-operation ("7 day-follow-up-visit"), whichever occurs first or, if applicable, until completion of the follow-up assessments ("follow-up visit"). However, a participant is considered enrolled in the WIN Study after having signed the informed consent form and when the WCS comes in contact with the participant.
The WIN Study will consist of the following treatments/follow-up visit:
- Screening will be performed within 28 days prior to the neurosurgical intervention.
- Neurosurgical intervention (by using the WCS and Comparator Device) will be divided in two phases: 1) "baseline phase" is foreseen at the beginning of the surgical procedure, before the surgical resection; 2) "IONM phase" is foreseen after the baseline phase when the lesion resection surgery will take place. During both phases, WCS safety and performance data will be collected, while the usability data will be collected after intervention.
- Neurological assessment within 24 hours following the neurosurgical intervention will be performed to evaluate if, during 24 hours after surgical intervention, Wise Cortical Strip-related (Serious) Adverse Effects happened.
- Discharge or 7 day-follow-up visit, whichever occurs first, will be performed to assess for safety related events ((Serious) Adverse Effects).
- Follow-up visit: should Wise Cortical Strip-related (Serious) Adverse Effect at discharge or 7 day-follow-up-visit be not resolved, the subject will be followed-up until (Serious) Adverse Effect resolution ("follow-up visit"). If a non-Wise Cortical Strip-related (Serious) Adverse Effect at discharge or 7 day-follow-up-visit is not resolved, it will be followed-up as per hospital standard of care.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Adult Epilepsy||Device: Wise Cortical Strip||Not Applicable|
|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. Both devices will be used during the "baseline phase". During "IONM phase", instead, the WCS is intended to remain on the brain surface, while the comparator device will be used according to physician's discretion (together with the WCS).|
|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 during the "baseline phase". The duration of the "baseline phase" is estimated to be within 10 minutes, considering simultaneous recordings from the WCS and the comparator device. During "IONM phase", the WCS and (if applicable) the comparator device will remain on the brain surface for performing intraoperative neurophysiological monitoring. The duration of the "IONM phase" depends on patient's brain lesion type and localization and will not be affected by the WIN Study.
Device: Wise Cortical Strip
The Wise Cortical Strip is a medical device composed by a strip, to be positioned on the exposed surface of the brain, and by a cable, that allows the transmission of the electrical signals to and from a commercial connecting cable.
- Serious Adverse Device Effects (SADEs) of the Wise Cortical Strip. [ Time Frame: Up to 24 hours following the surgical procedure. ]The incidence of patients with at least one SADE will be constructed and compared to a value of 10.3%, indicating the upper end of the range of SADE incidence rates observed in current practice.
- The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals. [ Time Frame: During the "baseline phase" of the surgical procedure. ]The difference between the Signal-to-Noise Ratio percentage (SNR%) calculated from Somatosensory Evoked Potential (SEP) signals acquired by the Wise Cortical Strip device and SNR% calculated from SEP signals acquired by comparator device on the same patient.
- Impedance values measured for the Wise Cortical Strip. [ Time Frame: During the entire surgical intervention. ]Preservation of the device impedance values below an acceptable level defined at 10 kΩ.
- Motor Evoked Potentials (MEPs). [ Time Frame: At the beginning of the "IONM phase" during surgical intervention. ]MEP peak-to-peak amplitude > 20 µV at latency compatible with the recruited muscular fiber.
- Dedicated usability questionnaire. [ Time Frame: The usability of the Wise Cortical Strip will be assessed from the beginning up to the end of the surgical procedure. ]Adequacy of the Wise Cortical Strip to its intended use will be summarized via user responses to a post-operative questionnaire.
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|