Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-06 @ 1:35 PM
Study NCT ID:
NCT02779400
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2015-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of measurement of the INR with the study device', 'timeFrame': 'Just after the blood taken at day 1', 'description': 'The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.'}], 'secondaryOutcomes': [{'measure': 'Repeatability of measurement of the INR with the study device', 'timeFrame': 'Just after the blood taken at day 1', 'description': 'Comparison of 8 INR measurements performed with the device in a range of 15 minutes.'}, {'measure': 'Reproductibility of measurement of the INR with the study device', 'timeFrame': 'Just after the blood taken at day 1', 'description': 'Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['INR', 'coagulation', 'vitamin K antagonist'], 'conditions': ['Healthy', 'Heart Valves', 'Arrhythmias, Cardiac', 'Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).', 'detailedDescription': 'The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.\n\nThe evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.\n\nThe INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.\n\nA total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with vitamin K agonist or healthy volunteers\n* For healthy volunteers : Body Mass index between 18 ans 29 kg/m²\n* No acute disease in the previous month\n\nExclusion Criteria:\n\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT02779400', 'acronym': 'HEMOPTICS2', 'briefTitle': 'Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)', 'orgStudyIdInfo': {'id': 'DCIC/14/54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of the device perfomance', 'interventionNames': ['Device: Self testing INR device']}], 'interventions': [{'name': 'Self testing INR device', 'type': 'DEVICE', 'otherNames': ['In vitro diagnostic device measuring INR'], 'description': 'the procedure involves a series of repeated measurements of INR with the studied device', 'armGroupLabels': ['Evaluation of the device perfomance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Clinical research center of Grenoble university hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}