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WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

NCT03731455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

WISE Cortical Strip

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

Sponsors & Collaborators

  • Genae

    collaborator INDUSTRY

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Wise S.r.l.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2020-01-20
Completion
2020-01-20

Countries

  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731455 on ClinicalTrials.gov