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

Not Applicable

Recruiting

• Conditions: Stroke; Stroke, Acute; Stroke, Ischemic; Stroke Hemorrhagic; Stroke, Cardiovascular
• Interventions: Diagnostic Test: CVAid Flow

• Registration Number: NCT05745051
• Lead Sponsor: Cvaid Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke	CVAid Flow	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm	after 24 hours	Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).

Secondary Outcome Measures

Name	Time	Method
Device operational performance	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

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel