Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-09 @ 6:44 AM
Study NCT ID:
NCT06291493
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Study Measuring Potassium (K) in Capillary Specimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Capillary precision analysis will be performed for Potassium K.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Precision for Potassium (K) Test', 'timeFrame': 'Up to 5 minutes', 'description': 'Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Precision of Potassium (K) Test in Capillary Whole Blood']}, 'descriptionModule': {'briefSummary': 'Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.', 'detailedDescription': 'The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated consent form (if required by the IRB)\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n• Prior enrollment in the study'}, 'identificationModule': {'nctId': 'NCT06291493', 'briefTitle': 'Precision Study Measuring Potassium (K) in Capillary Specimens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Point of Care'}, 'officialTitle': 'Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer', 'orgStudyIdInfo': {'id': 'CS-2024-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Precision assessment of Potassium (K) test in capillary blood sample', 'description': 'Prospectively collected capillary specimens from two separate fingerstick blood draws.', 'interventionNames': ['Diagnostic Test: Fingerstick blood draw']}], 'interventions': [{'name': 'Fingerstick blood draw', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Blood draw'], 'description': 'Capillary blood specimen collected from two separate fingerstick blood draws.', 'armGroupLabels': ['Precision assessment of Potassium (K) test in capillary blood sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore (UMD)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center (Hershey)', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '98052', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastside Research Associates (ERA)', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}, {'zip': 'K2H 8V4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Abbott Point of Care (APOC)', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Manish Gupta, BS, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Point of Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Point of Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}