NCT03767842

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 3, 2018

Last Update Submit

December 5, 2018

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Visor SystemDEVICE

Subjects are monitored one time with the Visor System.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting for evaluation of acute stroke

You may qualify if:

  • Being evaluated as a suspected stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

RECRUITING

Related 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-2017-013690. Epub 2018 Mar 6.

    PMID: 29511114RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher P Kellner, MD

    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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Parker

CONTACT

978-409-0451aparker@vastrax.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 7, 2018

Study Start

July 18, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)