Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke (VOICE)

  • STATUS
    Recruiting
  • End date
    Feb 18, 2026
  • participants needed
    880
  • sponsor
    NovaSignal Corp.
Updated on 18 October 2022

Summary

This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.

Description

The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.

Details
Condition Stroke, Acute Ischemic Stroke
Treatment NovaGuide 2 Intelligent Ultrasound System
Clinical Study IdentifierNCT05547412
SponsorNovaSignal Corp.
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject aged 18 years and older referred for evaluation of possible stroke
Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke
Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol

Exclusion Criteria

Head CT findings consistent with acute primary intracranial hemorrhage (SAH, ICH, etc.)
Subjects with occlusions in the distal or posterior circulation arteries
Subjects who underwent partial or full craniotomy
Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
Subjects who have a physical limitation preventing placement of the system
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