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

C

Cvaid Medical

Status

Enrolling

Conditions

Stroke, Cardiovascular
Stroke
Stroke Hemorrhagic
Stroke, Acute
Stroke, Ischemic

Treatments

Diagnostic Test: CVAid Flow

Study type

Interventional

Funder types

Industry

Identifiers

NCT05745051
0091-22-SZMC

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke
Experimental group
Description:
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.
Treatment:
Diagnostic Test: CVAid Flow

Trial contacts and locations

1

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Central trial contact

Oren Dror

Data sourced from clinicaltrials.gov

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