Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-26 @ 11:41 PM
Study NCT ID:
NCT07287618
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using 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': 'Method Comparison Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 425}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.', 'timeFrame': 'Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.', 'description': 'Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens.\n\nSubjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Potassium (K) ionized calcium (iCa)'], 'conditions': ['Hematologic Tests']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the performance of blood tests using the i-STAT 1 System against a comparator blood analysis system.', 'detailedDescription': 'To compare the performance of the i-STAT potassium (K) and ionized calcium (iCa) tests using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer to the performance of K and iCa tests on a comparator blood analysis system using results from two separate capillary specimens from each subject enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)\n2. ≥ 18 years of age\n\nExclusion Criteria:\n\n1\\. Previous enrollment in this study'}, 'identificationModule': {'nctId': 'NCT07287618', 'briefTitle': 'Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using Capillary Specimens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Point of Care'}, 'officialTitle': 'Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens', 'orgStudyIdInfo': {'id': 'CS-2025-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Method comparison for K and iCa tests using capillary whole blood specimens.', 'description': 'Performance comparison: Using results from capillary whole blood specimens collected from fingerstick(s) from each subject enrolled in the study, the performance between i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on i-STAT 1 analyzer and a comparator blood analysis system will be compared.', 'interventionNames': ['Diagnostic Test: Blood draw']}], 'interventions': [{'name': 'Blood draw', 'type': 'DIAGNOSTIC_TEST', 'description': 'Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.', 'armGroupLabels': ['Method comparison for K and iCa tests using capillary whole blood specimens.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin T Baca, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael H Creer, MD', 'role': 'CONTACT'}], 'facility': 'Penn State Health Milton S. Hershey Medical Center (Hershey)', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tom Aufderheide, MD', 'role': 'CONTACT', 'phone': '414-955-1174'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Miranda Gonzalez Aguirre, PhD', 'role': 'CONTACT', 'email': 'miranda.gonzalezaguirre@abbott.com', 'phone': '613-604-8539'}], 'overallOfficials': [{'name': 'Manish Gupta, MS, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Point of Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Point of Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}