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

Sponsor

Cvaid Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05745051

Collaborator

(none)

100

Enrollment

Location

Arm

7.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Acute Stroke, Ischemic Stroke, Cardiovascular Stroke Hemorrhagic	Diagnostic Test: CVAid Flow	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 8, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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).

Arm

Intervention/Treatment

Experimental: Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke

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).

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm [At admission]
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
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

Device operational performance [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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaare Zedek Medical Center	Jerusalem		Israel

Sponsors and Collaborators

Cvaid Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cvaid Medical

ClinicalTrials.gov Identifier:

NCT05745051

Other Study ID Numbers:

0091-22-SZMC

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Hemorrhagic Stroke

Myocardial Infarction

Ischemia

Study Results

No Results Posted as of Feb 27, 2023