The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

August 29, 2023 updated by: Cvaid Medical

A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:

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

Description

Inclusion Criteria:

  • Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT)
  • Age≥18

Exclusion Criteria:

  • Intubated patients upon arrival
  • Time from stroke symptoms onset > 24h
  • Patients post treatment (tPA of EVT)
  • Patient in acute psychosis state
  • Patients who do not speak Hebrew as their mother tongue

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke
The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.
Diagnostic test: CVAid Flow
CVA-FLOW is a Telestroke mobile software solution that enables the neurologist to remotely assess, on his smartphone, patients suspected with stroke. Real-time, objective, patient-specific data such as images, videos and vocal records of the patient, are acquired by a first responder (CVA-COLLECTOR) at the patient's location. This allows the neurologist to complete the NIH Stroke Scale and independently reach a diagnostic conclusion and treatment plan (CVA-MED).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Time Frame: At admission
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
At admission
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Time Frame: after 24 hours
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
after 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device operational performance
Time Frame: At admission

The investigator shall assess the use of the device during the operation, and conclude a summary evaluation after the end of the usage. Evaluation items are shown below:Item / evaluation

  • Usage experience: Simple to operate/difficult to operate
  • Errors: No errors occurs during the usage/ Errors occurs during the usage
  • Known safety issues during use of CVA-MED and CVA-COLLECTOR
At admission
Device operational performance
Time Frame: after 24 hours

The investigator shall assess the use of the device during the operation, and conclude a summary evaluation after the end of the usage. Evaluation items are shown below:Item / evaluation

  • Usage experience: Simple to operate/difficult to operate
  • Errors: No errors occurs during the usage/ Errors occurs during the usage
  • Known safety issues during use of CVA-MED and CVA-COLLECTOR
after 24 hours

Collaborators and Investigators

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

Sponsor

Cvaid Medical

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)

November 8, 2022

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0091-22-SZMC

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

No

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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