Last updated on May 2020

Wise Cortical Strip for Intraoperative Neurophysiological Monitoring

Brief description of 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 (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.

Detailed Study Description

The IONM is the use of electrophysiological methods to identify important neural structures in the operative field, including eloquent areas (i.e. areas that if removed or damaged would imply a loss of motor or language or sensory or vision abilities), 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 SEPs and ECoG recording and brain stimulation, aimed to elicit MEPs.

A clinical evaluation has been performed during the development phase of the WCS, to investigate whether there is sufficient clinical evidence to demonstrate conformity of the WCS to the MDD Essential Requirements covering safety, clinical performance and intended use and to identify data that need to be generated for first market access. The relevant clinical data collected on devices similar to the WCS are consistent with the current state of the art, and demonstrate the safety, clinical performance and an overall acceptable risk/benefit ratio of devices similar to the WCS when used according to the intended purpose in the target treated population. However, since no devices currently on the market have been identified as strictly equivalent to the WCS, these data cannot be used to support the safety, clinical performance and intended use of the WCS. However, the results of the preclinical tests on WCS, including a comprehensive study on sheep model, showed that the WCS is safe to use as-is, and that its performances make the device suitable to be used in a clinical context for the IONM.

Based on the results of the clinical evaluation and of the conducted pre-clinical tests, some open points remain to be addressed at a clinical stage to confirm compliance of the WCS to the MDD Essential Requirements and thus to undergo conformity assessment for WCS CE certification. These open points are:

  • the safety of the WCS during a neurosurgical intervention conducted on humans, since during the pre-clinical in vivo study on sheep model the intraoperative neurophysiological monitoring was performed on the intact surface of the brain, exactly as on humans, but without any ongoing neurosurgical intervention comparable to those procedures conducted in participants with brain tumors or epilepsies.
  • the clinical performance of the WCS during a neurosurgical intervention conducted on humans, to prove the clinical relevance of recordings and stimulations performed through the WCS during an IONM procedure performed in a real clinical setting, where sources of interference, not evaluated during pre-clinical testing, can be present.
  • the usability of the WCS during a neurosurgical intervention conducted on human, to ensure the adequacy of the WCS to its intended use from users' perspective. In addition, since only one neurosurgeon was involved in the usability evaluation during the preclinical study in-vivo, further usability data need to be acquired on a more representative sample of users, including also neurophysiologists.

These open points will be verified during the WIN Study. The "baseline phase" will be conducted with the participant asleep under a constant anesthesiologic level and the duration of the "baseline phase" will be dependent on data collection and is estimated to be within 10 minutes, considering simultaneous recordings from the WCS and the comparator device. During "IONM phase", instead, the WCS is intended to remain on the brain surface for intraoperative neurophysiological monitoring during the intervention. The duration of the "IONM phase" depends on patient's brain lesion type and localization and will not be affected by the WIN Study. In this phase, the WCS and (if applicable) the comparator device will be used for performing intraoperative neurophysiological monitoring by means of electrophysiological parameters such as MEPs, SEPs, ECoG, according to the site clinical practice.

Clinical Study Identifier: NCT03731455

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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