Wise Cortical Strip for Intraoperative Neurophysiological Monitoring

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Brief Title

Wise Cortical Strip for Intraoperative Neurophysiological Monitoring

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)

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 (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 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.
    


Study Type

Interventional


Primary Outcome

Serious Adverse Device Effects (SADEs) of the Wise Cortical Strip.

Secondary Outcome

 Impedance values measured for the Wise Cortical Strip.

Condition

Brain Tumor Adult

Intervention

Wise Cortical Strip

Study Arms / Comparison Groups

 Investigational and Comparator devices
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

April 9, 2019

Completion Date

January 20, 2020

Primary Completion Date

January 20, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Brain tumor or epilepsy that require neurosurgical intervention and exposure of the
             central region of the cerebral cortex including at least the hand-forearm areas in the
             primary motor cortex and the primary somatosensory cortex (i.e. excision of lesion,
             open approach)

          -  Age: 18 - 75 years at the time of enrollment

          -  Required intraoperative neurophysiological monitoring with subdural electrodes

          -  Willingness to provide informed consent for participating in the study

        Exclusion Criteria:

          -  Significant psychiatric impairments which, in the opinion of the investigator, will
             interfere with the proper administration or completion of the protocol

          -  Acute or untreated infections (viral, bacterial or fungal)

          -  Currently on any anticoagulant medication that cannot be discontinued during the
             perioperative period, or patients with factor XIII deficiency or any other
             hematological disease

          -  Current treatment with antibiotics

          -  Patients with a previous a craniotomy within the vicinity of the central region

          -  A female that is breastfeeding or of child bearing potential with a positive urine
             pregnancy test or not using adequate contraception.

          -  A co-morbid disease or condition that could confound the neurological and functional
             evaluations or compromise survival

          -  Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as
             frequent or daily consumption of more than four alcoholic drinks per day)

          -  Active participation in another investigational device study

          -  Any other condition that in the opinion of the investigator may adversely affect the
             safety of the subject or would limit the subject's ability to complete the study
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03731455

Organization ID

001_WCS


Responsible Party

Sponsor

Study Sponsor

Wise S.r.l.

Collaborators

 Genae

Study Sponsor

, , 


Verification Date

January 2020