VIGOR: Volumetric Impedance to Guide Stroke Response
Sponsor
Cerebrotech Medical Systems, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03767842
Collaborator
(none)
316
1
8.4
37.6
Study Details
Study Description
Brief Summary
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
316 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Volumetric Impedance to Guide Stroke Response
Actual Study Start Date
:
Jul 18, 2018
Anticipated Primary Completion Date
:
Mar 31, 2019
Anticipated Study Completion Date
:
Mar 31, 2019
Outcome Measures
Primary Outcome Measures
- Hemispheric bioimpedance asymmetry sensitivity and specificity [At the time of device monitoring - day 0]
Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Being evaluated as a suspected stroke
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Buffalo Neurosurgery | Buffalo | New York | United States | 14203 |
Sponsors and Collaborators
- Cerebrotech Medical Systems, Inc.
Investigators
- Principal Investigator: Christopher P Kellner, MD, Mt Sinai Health System
- Principal Investigator: Andrei V Alexandrov, MD, University of Tennessee Health Science Center
- Principal Investigator: Raul G Nogueira, MD, Emory University School of Medicine, Grady Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cerebrotech Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT03767842
Other Study ID Numbers:
- CH007
First Posted:
Dec 7, 2018
Last Update Posted:
Dec 7, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: