Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 3:06 PM
Study NCT ID:
NCT02586818
Status:
WITHDRAWN
Last Update Posted:
2021-08-30
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Product was discontinued.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-23', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of INR measurements', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Dyscrasia']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population to be studied consists of subjects who require oral anticoagulant therapy with VKA in accordance with the approved label indications for VKA administration. Normal healthy individuals will also be enrolled to collect data to support the low end of the lnRhythm system detection range.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - All\n\n* The subjects must be \\> 18 years of age.\n* The subjects must be willing and competent to sign an informed consent.\n* The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.\n\nExclusion Criteria - All\n\n* The subject is unable to donate fingerstick and venous blood samples.\n* The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.\n* The subject is enrolled in any other study that involves an investigational drug and/or device.\n\nAdditional Inclusion Criteria - Therapeutic Group\n\n* The subject must require oral VKA anticoagulant therapy.\n* The patient must have been anticoagulated for at least three months prior to enrollment.\n\nAdditional Exclusion Criteria - Normal Group\n\n\\- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.'}, 'identificationModule': {'nctId': 'NCT02586818', 'briefTitle': 'Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accriva Diagnostics'}, 'officialTitle': 'Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting', 'orgStudyIdInfo': {'id': 'INR_CSP_015_0002_RA'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accriva Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Rochester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}