Back to resultsThe Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
Primary Purpose
Stroke, Stroke, Acute, Stroke, Ischemic
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CVAid Flow
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Shaare Zedek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke
Arm 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.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05745051
Brief Title
The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
Official Title
A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cvaid Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Cardiovascular, Stroke Hemorrhagic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CVAid Flow
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Description
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
Time Frame
At admission
Title
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Description
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
Time Frame
after 24 hours
Secondary Outcome Measure Information:
Title
Device operational performance
Description
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
Time Frame
At admission
Title
Device operational performance
Description
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
Time Frame
after 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Dror
Phone
+972 54-922-5676
Email
oren@cvaidmedical.com
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Valdman
Phone
972549577137
Email
ruthva@szmc.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
We'll reach out to this number within 24 hrs