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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745051
• Other study ID #: 0091-22-SZMC
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: August 2023
• Source: Cvaid Medical
• Contact: Oren Dror
• Phone: +972 54-922-5676
• Email: oren[@]cvaidmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemia
• Ischemic Stroke
• Myocardial Infarction
• Stroke
• Stroke Hemorrhagic
• Stroke, Acute
• Stroke, Cardiovascular
• Stroke, Ischemic

Intervention

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).

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Cvaid Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm	Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).	At admission
Primary	Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm	Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).	after 24 hours
Secondary	Device operational performance	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
Secondary	Device operational performance	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