Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-24 @ 1:41 PM
Study NCT ID:
NCT06905392
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification 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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation', 'timeFrame': '5 month', 'description': 'To establish a correlation between sample matrices'}, {'measure': 'Stability', 'timeFrame': '5 month', 'description': 'To determine sample stability with the NTproBNP2 Test Kit on the AQT90 FLEX analyzer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diagnostic Tests']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.'}, '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 Test Kit.', '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 Test Kit.\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': 'NCT06905392', 'briefTitle': 'AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radiometer Medical ApS'}, 'officialTitle': 'AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study', 'orgStudyIdInfo': {'id': 'DC-087459'}}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Brown, PhD', 'role': 'CONTACT', 'email': 'Hannah.Brown@hcmed.org', 'phone': '+ 1 612-873-6893'}, {'name': 'Karen Schulz', 'role': 'CONTACT', 'email': 'KSchulz@hhrinstitute.org', 'phone': '+ 1 612-873-6893'}, {'name': 'Hannah Brown, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hennepin Healthcare (Research Institute/ Minneapolis Medical Research Foundation)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Murcia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Estíbaliz Alegre Martínez, Dr.', 'role': 'CONTACT', 'email': 'ealegre@unav.es', 'phone': '+34948255400'}, {'name': 'Alvaro Gonzalez Hernandez, Dr.', 'role': 'CONTACT', 'email': 'agonzaleh@unav.es', 'phone': '+34948255400'}], 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Santiago de Compostela', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gonzalez', 'role': 'CONTACT', 'email': 'Jose.Ramon.Gonzalez.Juanatey@sergas.es', 'phone': '+34981955740'}], 'facility': 'Hospital Clinico Universitario de Santiago Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Ùbeda', 'status': 'ACTIVE_NOT_RECRUITING', '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'}}}}