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:
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03731455 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Wise S.r.l. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
Overall Status | Recruiting |
Countries | Germany, Italy, Switzerland |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain Tumor Adult, Epilepsy |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.