Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05745051
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2023-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm', 'timeFrame': 'At admission', 'description': 'Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).'}, {'measure': 'Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm', 'timeFrame': 'after 24 hours', 'description': 'Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).'}], 'secondaryOutcomes': [{'measure': 'Device operational performance', 'timeFrame': 'At admission', '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\n\n* Usage experience: Simple to operate/difficult to operate\n* Errors: No errors occurs during the usage/ Errors occurs during the usage\n* Known safety issues during use of CVA-MED and CVA-COLLECTOR'}, {'measure': 'Device operational performance', 'timeFrame': 'after 24 hours', '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\n\n* Usage experience: Simple to operate/difficult to operate\n* Errors: No errors occurs during the usage/ Errors occurs during the usage\n* Known safety issues during use of CVA-MED and CVA-COLLECTOR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Stroke, Acute', 'Stroke, Ischemic', 'Stroke, Cardiovascular', 'Stroke Hemorrhagic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT)\n* Ageā„18\n\nExclusion Criteria:\n\n* Intubated patients upon arrival\n* Time from stroke symptoms onset \\> 24h\n* Patients post treatment (tPA of EVT)\n* Patient in acute psychosis state\n* Patients who do not speak Hebrew as their mother tongue'}, 'identificationModule': {'nctId': 'NCT05745051', 'briefTitle': 'The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cvaid Medical'}, 'officialTitle': 'A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '0091-22-SZMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke', '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.', 'interventionNames': ['Diagnostic Test: CVAid Flow']}], 'interventions': [{'name': 'CVAid Flow', 'type': 'DIAGNOSTIC_TEST', '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).", 'armGroupLabels': ['Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ruth Valdman', 'role': 'CONTACT', 'email': 'ruthva@szmc.org.il', 'phone': '972549577137'}], 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Oren Dror', 'role': 'CONTACT', 'email': 'oren@cvaidmedical.com', 'phone': '+972 54-922-5676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cvaid Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}