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

March 14, 2024 updated by: NovaSignal Corp.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

27

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

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • CHI Memorial Hospital

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

No

Sampling Method

Probability Sample

Study Population

Subjects will be enrolled from Stroke centers in the U.S.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort X
Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.
Device: NovaGuide 2 Intelligent Ultrasound System
The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.
Cohort Y
Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.
Cohort A
Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2
Device: NovaGuide 2 Intelligent Ultrasound System
The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.
Cohort B
Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2
Device: NovaGuide 2 Intelligent Ultrasound System
The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.
Cohort C
Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2
Cohort D
Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.
Time Frame: 1 day
The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoint: Incidence of device-related serious adverse events
Time Frame: 42 months
Measuring incidence of device-related serious adverse events as defined by the study protocol.
42 months
Safety Endpoint: Last Known Normal (LKN) to first hospital arrival (initial door-in) time
Time Frame: 42 months
Measuring the time from the subject's last known normal health to the time the subject first arrive in the hospital.
42 months
Safety Endpoint: Door to initial CT imaging (non-contrast) time
Time Frame: 42 months
Measuring the time from when the subject first arrive at the hospital to the time the subject receives the initial CT imaging.
42 months
Safety Endpoint: Door to IV-tPA time
Time Frame: 42 months
Measuring the time from when the subject first arrive at the hospital to the time the subject receives IV-tPA
42 months
Safety Endpoint: Door to initial CTA acquisition time
Time Frame: 42 months
Measuring the time from when the subject first arrive at the hospital to the time the initial CTA was acquired.
42 months
Safety Endpoint: Door to Groin Puncture time
Time Frame: 42 months
Measuring the time from when the subject first arrive at the hospital to the time the groin was punctured.
42 months
Safety Endpoint: CTA Acquisition to Groin Puncture time
Time Frame: 42 months
Measuring the time from the CTA acquisition to the time the groin was punctured
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovaSignal Corp.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Robert Hamilton, Ph.D., NovaSignal Corp.

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.

General Publications

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)

September 21, 2022

Primary Completion (Actual)

January 16, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA-01STR-03
  • U44NS109952 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

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