Volumetric Impedance to Guide Stroke Response (VIGOR)
December 5, 2018 updated by: Cerebrotech Medical Systems, Inc.
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry
Study Overview
Study Type
Observational
Enrollment (Anticipated)
316
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Buffalo, New York, United States, 14203
- Recruiting
- University of Buffalo Neurosurgery
-
Contact:
- Adrian Parker
- Phone Number: 978-409-0451
- Email: aparker@vastrax.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presenting for evaluation of acute stroke
Description
Inclusion Criteria:
- Being evaluated as a suspected stroke
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemispheric bioimpedance asymmetry sensitivity and specificity
Time Frame: At the time of device monitoring - day 0
|
Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke
|
At the time of device monitoring - day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher P Kellner, MD, Mt Sinai Health System
- Principal Investigator: Andrei V Alexandrov, MD, University of Tennessee
- Principal Investigator: Raul G Nogueira, MD, Emory University School of Medicine, Grady Memorial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2018
Primary Completion (Anticipated)
March 31, 2019
Study Completion (Anticipated)
March 31, 2019
Study Registration Dates
First Submitted
December 3, 2018
First Submitted That Met QC Criteria
December 5, 2018
First Posted (Actual)
December 7, 2018
Study Record Updates
Last Update Posted (Actual)
December 7, 2018
Last Update Submitted That Met QC Criteria
December 5, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.