Volumetric Impedance to Guide Stroke Response

Stroke, Acute Clinical Trial

— VIGOR  

Official title:

Volumetric Impedance to Guide Stroke Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767842
• Other study ID #: CH007
• Status: Recruiting
• Start date: July 18, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2018
• Source: Cerebrotech Medical Systems, Inc.
• Contact: Adrian Parker
• Phone: 978-409-0451
• Email: aparker[@]vastrax.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being evaluated as a suspected stroke

Exclusion Criteria:

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Visor System
Subjects are monitored one time with the Visor System.

Locations

Country	Name	City	State
United States	University of Buffalo Neurosurgery	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cerebrotech Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemispheric bioimpedance asymmetry sensitivity and specificity	Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke	At the time of device monitoring - day 0