Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-12 @ 7:41 AM
Study NCT ID:
NCT03133351
Status:
UNKNOWN
Last Update Posted:
2020-04-16
First Post:
2017-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCM Clotting Time (CT)', 'timeFrame': 'Testing to be initiated within 4 minutes of sample collection', 'description': 'To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured.'}, {'measure': 'Clot Formation Time (CFT)', 'timeFrame': 'Testing to be initiated within 4 minutes of sample collection', 'description': 'To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.'}, {'measure': 'Alpha Angle (AA)', 'timeFrame': 'Testing to be initiated within 4 minutes of sample collection', 'description': 'To define the PCM normal laboratory reference range, alpha angle (AA) will be measured.\n\nTo define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.'}, {'measure': 'Maximum Clot Firmness (MCF)', 'timeFrame': 'Testing to be initiated within 4 minutes of sample collection', 'description': 'To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured.'}, {'measure': '30-minutes Lysis after CT (LI30)', 'timeFrame': 'Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT', 'description': 'To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured.'}, {'measure': '45-minutes Lysis after CT (LI45)', 'timeFrame': 'Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT', 'description': 'To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coagulation']}, 'descriptionModule': {'briefSummary': 'This study is intended to define the PCM normal laboratory range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'genderDescription': '120 Males and 120 Females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)\n3. Normal vital signs at screening\n\nExclusion Criteria:\n\n1. Current daily tobacco use or previous recreational drug use\n2. Pregnant or lactating at the time of the study\n3. Currently taking any medications known to affect coagulation\n4. History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases\n5. Current diagnosis of cancer'}, 'identificationModule': {'nctId': 'NCT03133351', 'briefTitle': 'Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entegrion, Inc.'}, 'officialTitle': 'Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PCM-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCM', 'description': 'All enrolled subjects will have a blood sample tested using PCM.', 'interventionNames': ['Device: PCM']}], 'interventions': [{'name': 'PCM', 'type': 'DEVICE', 'otherNames': ['Point of Care Coagulation Monitor'], 'description': 'A fresh whole blood sample will be tested by PCM to determine the reference range.', 'armGroupLabels': ['PCM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entegrion, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}