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Wise Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731455
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Genae
Fondazione Don Carlo Gnocchi Onlus
Information provided by (Responsible Party):
Wise S.r.l.

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Adult Epilepsy Device: Wise Cortical Strip Not Applicable

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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)
Primary Purpose: Other
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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

Information from the National Library of Medicine

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


Locations
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Germany
Klinikum der Universitat München
Munich, Germany, 81377
Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)
Verona, Italy, 37126
Switzerland
Inselspital
Bern, Switzerland, 3010
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Universitätsspital
Zürich, Switzerland, 8091
Sponsors and Collaborators
Wise S.r.l.
Genae
Fondazione Don Carlo Gnocchi Onlus

Publications:
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Responsible Party: Wise S.r.l.
ClinicalTrials.gov Identifier: NCT03731455    
Other Study ID Numbers: 001_WCS
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wise S.r.l.:
Cortical strip
Electrode