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Clinical Trials/NCT05745051
NCT05745051
Recruiting
Not Applicable

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

Cvaid Medical1 site in 1 country100 target enrollmentNovember 8, 2022
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ConditionsStrokeStroke, AcuteStroke, IschemicStroke, CardiovascularStroke Hemorrhagic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Cvaid Medical
Enrollment
100
Locations
1
Primary Endpoint
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2022
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cvaid Medical
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Device operational performance(after 24 hours)

Study Sites (1)

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