Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT06078956
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ABL90 Flex Plus Method Comparison Study_Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 754}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slope, R^2 and bias at medical decision points', 'timeFrame': '6-9 months', 'description': 'Primary Endpoints: Slope, R\\^2 and bias at medical decision points for each combination of modes and sample type, across sites'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood gas'], 'conditions': ['Diagnostic Test']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood in a Point of Care (POC) setting.', 'detailedDescription': 'The main question it aims to answer is:\n\nTo quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must be 18 years or older.\n* Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.\n* The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick.\n* Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.\n\nExclusion Criteria:\n\n* Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.\n* Subject, who is pregnant or breastfeeding.\n* Subject, who has an invalid written informed consent or has withdrawn consent.\n* Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode\n* Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference.\n* Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).'}, 'identificationModule': {'nctId': 'NCT06078956', 'briefTitle': 'ABL90 Flex Plus Method Comparison Study_Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radiometer Medical ApS'}, 'officialTitle': 'ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.', 'orgStudyIdInfo': {'id': 'DC-083659'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Investigational Device', 'interventionNames': ['Device: Measuring of analytes']}, {'type': 'OTHER', 'label': 'Predicate device', 'interventionNames': ['Device: Measuring of analytes']}], 'interventions': [{'name': 'Measuring of analytes', 'type': 'DEVICE', 'description': 'Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in whole blood in adult population.', 'armGroupLabels': ['Investigational Device', 'Predicate device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Lisbet Bærentzen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiometer Medical ApS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiometer Medical ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}