Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT06693050
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-11-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slope, R', 'timeFrame': '5 month', 'description': 'Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diagnostic Test']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.\n* Subjects must be 18 years of age or older.\n* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.\n\nExclusion Criteria:\n\n* Subjects known to be pregnant or breast-feeding.\n* Subjects previously enrolled in the study.\n* Subject, who has withdrawn consent.'}, 'identificationModule': {'nctId': 'NCT06693050', 'briefTitle': 'AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radiometer Medical ApS'}, 'officialTitle': 'AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study', 'orgStudyIdInfo': {'id': 'DC-087457'}}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospiltal Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ùbeda', 'country': 'Spain', 'facility': 'Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiometer Medical ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}