A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW
NCT06101004 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 460
Last updated 2023-10-25
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.
Conditions
Interventions
- DEVICE
-
CVA-Flow
CVA-FLOW Software Device is indicated for the detection of Stroke and LVO in patients with suspected stroke.
Sponsors & Collaborators
-
Donawa Lifescience Consulting
collaborator UNKNOWN -
Cvaid Medical
lead INDUSTRY
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-23
- Primary Completion
- 2024-05-30
- Completion
- 2024-05-30
- FDA Device
- Yes
Countries
- United States
- Spain
Study Locations
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