A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW
1 other identifier
observational
460
2 countries
2
Brief Summary
CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedOctober 25, 2023
October 1, 2023
7 months
October 17, 2023
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Co-primary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with stroke among all suspected patients.
The co-primary endpoints are defined as follows, Reference for each case shall be scored by the reviewer neurologist dichotomously as: * Positive - at least one relevant finding, or; * Negative - no relevant findings. Each case shall also be scored dichotomously by CVA-Flow software as: * Positive - suspected stroke, or; * Negative - no suspected stroke.
From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
Secondary Outcomes (1)
Confirmatory secondary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with LVO stroke among all suspected patients without head bleeding.
From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
Interventions
CVA-FLOW Software Device is indicated for the detection of Stroke and LVO in patients with suspected stroke.
Eligibility Criteria
Patients with suspected acute stroke at the ED prior to treatment (tPA or EVT)
You may qualify if:
- Age ≥21 years of age
- With suspected acute stroke at the ED prior to treatment (tPA or EVT)
You may not qualify if:
- Patient intubated upon arrival
- Patient treated with tPA prior to arrival at the ED
- Patients with the following conditions:
- Brain tumors
- Hypoglycemia
- Toxic poisoning
- Seizures
- Sepsis
- Subdural hematoma
- Encephalopathy (uremic, hepatic or other)
- Encephalitis
- Previous stroke with permanent neurological deficit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cvaid Medicallead
- Donawa Lifescience Consultingcollaborator
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Hospital Vall d'Hebron - Neurology
Barcelona, 08035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
October 25, 2023
Study Start
October 23, 2023
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share