A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW

October 23, 2023 updated by: Cvaid Medical

A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for the Detection of Stroke and LVO in Patients With Suspected Stroke

CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Management of acute ischemic stroke has changed dramatically following the evidence of the superiority of endovascular treatment (EVT) over best medical management, in the treatment of patients suffering large vessel occlusion (LVO), within 24 hours from onset of symptoms. The immediate consequence was an increase in the number of patients eligible for EVT, requiring secondary transfer of those patients from primary stroke centers to comprehensive stroke centers, capable of performing EVT.

EVT requires accurate and rapid diagnosis in the prehospital setting, as it is only indicated in specific patients with LVO, making up a small percentage of stroke cases, and its beneficial effects are highly time-dependent.

Of the existing diagnostic tools that accurately distinguish LVO cases from non-LVO ones, the National Institutes of Health Stroke Scale (NIHSS) is the most recommended tool by healthcare providers to objectively quantify the neurological impairment caused by a suspected stroke. Nevertheless, the NIHSS is not considered to be feasible in the pre-hospital setting of EMS, since it requires a greater degree of training, is thought to be too time-consuming, and has not been as well validated in the prehospital setting.

Several previous studies showed feasibility and reliability of the use of telemedicine for determining the NIHSS score from afar in stroke patients in real time, in simulated stroke patients in real time and captured video segments. Previous studies did not use designated applications designed for performing neurological evaluations, relying on simple applications for video conferencing instead, therefore requiring applicators to possess knowledge in performing neurological examinations and evaluators to be online the whole examination time.

To resolve this issue, CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron - Neurology
  • United States
    • New York
      • New York, New York, United States, 10029

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with suspected acute stroke at the ED prior to treatment (tPA or EVT)

Description

Inclusion Criteria:

  • Age ≥21 years of age
  • With suspected acute stroke at the ED prior to treatment (tPA or EVT)

Exclusion Criteria:

  • Patient intubated upon arrival
  • Patient treated with tPA prior to arrival at the ED

  • Patients with the following conditions:

    • Brain tumors
    • Hypoglycemia
    • Toxic poisoning
    • Seizures
    • Sepsis
    • Subdural hematoma
    • Encephalopathy (uremic, hepatic or other)
    • Encephalitis
  • Previous stroke with permanent neurological deficit

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-primary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with stroke among all suspected patients.
Time Frame: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks

The co-primary endpoints are defined as follows,

Reference for each case shall be scored by the reviewer neurologist dichotomously as:

  • Positive - at least one relevant finding, or;
  • Negative - no relevant findings.

Each case shall also be scored dichotomously by CVA-Flow software as:

  • Positive - suspected stroke, or;
  • Negative - no suspected stroke.
From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmatory secondary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with LVO stroke among all suspected patients without head bleeding.
Time Frame: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks

The confirmatory secondary endpoints are defined similarly to the co-primary endpoints as follows,

Reference for each case shall be scored by the reviewer radiologist dichotomously as:

  • Positive - at least one relevant finding (LVO), or;
  • Negative - no relevant findings.

Each case shall also be scored dichotomously by CVA-Flow software as:

  • Positive - suspected LVO, or;
  • Negative - no suspected relevant findings.
From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks

Collaborators and Investigators

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

Sponsor

Cvaid Medical

Collaborators

Donawa Lifescience Consulting

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 (Estimated)

October 23, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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