Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-17
Brief Title:
A Multi-center Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW
Sponsor:
Cvaid Medical
Organization:
Cvaid Medical
Study Overview
Official Title:
A Multi-center Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for the Detection of Stroke and LVO in Patients With Suspected Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CVAid Medical Ltd developed a smartphone-based tele stroke system named CVA-Flow This system aims to evaluate the patients neurological status particularly detection of a possible stroke assessment of stroke severity and prediction of LVO as the cause of stroke The systems 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 patients status manually
Detailed Description:
Management of acute ischemic stroke has changed dramatically following the evidence of the superiority of endovascular treatment EVT over best medical management in the treatment of patients suffering large vessel occlusion LVO within 24 hours from onset of symptoms The immediate consequence was an increase in the number of patients eligible for EVT requiring secondary transfer of those patients from primary stroke centers to comprehensive stroke centers capable of performing EVT
EVT requires accurate and rapid diagnosis in the prehospital setting as it is only indicated in specific patients with LVO making up a small percentage of stroke cases and its beneficial effects are highly time-dependent
Of the existing diagnostic tools that accurately distinguish LVO cases from non-LVO ones the National Institutes of Health Stroke Scale NIHSS is the most recommended tool by healthcare providers to objectively quantify the neurological impairment caused by a suspected stroke Nevertheless the NIHSS is not considered to be feasible in the pre-hospital setting of EMS since it requires a greater degree of training is thought to be too time-consuming and has not been as well validated in the prehospital setting
Several previous studies showed feasibility and reliability of the use of telemedicine for determining the NIHSS score from afar in stroke patients in real time in simulated stroke patients in real time and captured video segments Previous studies did not use designated applications designed for performing neurological evaluations relying on simple applications for video conferencing instead therefore requiring applicators to possess knowledge in performing neurological examinations and evaluators to be online the whole examination time
To resolve this issue CVAid Medical Ltd developed a smartphone-based tele stroke system named CVA-Flow This system aims to evaluate the patients neurological status particularly detection of a possible stroke assessment of stroke severity and prediction of LVO as the cause of stroke The systems 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 patients status manually
EVT requires accurate and rapid diagnosis in the prehospital setting as it is only indicated in specific patients with LVO making up a small percentage of stroke cases and its beneficial effects are highly time-dependent
Of the existing diagnostic tools that accurately distinguish LVO cases from non-LVO ones the National Institutes of Health Stroke Scale NIHSS is the most recommended tool by healthcare providers to objectively quantify the neurological impairment caused by a suspected stroke Nevertheless the NIHSS is not considered to be feasible in the pre-hospital setting of EMS since it requires a greater degree of training is thought to be too time-consuming and has not been as well validated in the prehospital setting
Several previous studies showed feasibility and reliability of the use of telemedicine for determining the NIHSS score from afar in stroke patients in real time in simulated stroke patients in real time and captured video segments Previous studies did not use designated applications designed for performing neurological evaluations relying on simple applications for video conferencing instead therefore requiring applicators to possess knowledge in performing neurological examinations and evaluators to be online the whole examination time
To resolve this issue CVAid Medical Ltd developed a smartphone-based tele stroke system named CVA-Flow This system aims to evaluate the patients neurological status particularly detection of a possible stroke assessment of stroke severity and prediction of LVO as the cause of stroke The systems 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 patients status manually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None