WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-09

Study Completion Date

2020-01-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Tumor Adult Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The neurosurgical intervention will be performed with both devices: investigational (Wise Cortical Strip, WCS) and comparator device.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Investigational and Comparator devices

Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together.

Group Type EXPERIMENTAL

WISE Cortical Strip

Intervention Type DEVICE

The WISE Cortical Strip is a medical device composed by a strip and by a cable.

Interventions

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WISE Cortical Strip

The WISE Cortical Strip is a medical device composed by a strip and by a cable.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. Age: 18 - 75 years at the time of enrollment
3. Required intraoperative neurophysiological monitoring with subdural electrodes
4. Willingness to provide informed consent for participating in the study

Exclusion critria:

1. Significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol
2. Acute or untreated infections (viral, bacterial or fungal)
3. Currently on any anticoagulant medication that cannot be discontinued during the perioperative period, or patients with factor XIII deficiency or any other hematological disease
4. Current treatment with antibiotics

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No