Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02843958
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2016-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Portable Medical Device for Diagnostic in Vitro
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Normalized Ratio measurement: comparison to the standard reference.', 'timeFrame': 'V2'}], 'secondaryOutcomes': [{'measure': 'International Normalized Ratio measurement: repeatability', 'timeFrame': 'V2'}, {'measure': 'International Normalized Ratio measurement:reproductibility', 'timeFrame': 'V2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medical device', 'Hemoptic', 'Vitamin K antagonist', 'Diagnostic in vitro'], 'conditions': ['Healthy Volunteer', 'Patients Under Vitamin K Antagonist (VKA)']}, 'referencesModule': {'references': [{'pmid': '16458764', 'type': 'BACKGROUND', 'citation': 'Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367(9508):404-11. doi: 10.1016/S0140-6736(06)68139-7.'}, {'pmid': '21639579', 'type': 'BACKGROUND', 'citation': 'Faivre M, Peltie P, Planat-Chretien A, Cosnier ML, Cubizolles M, Nougier C, Negrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813.'}, {'pmid': '20961244', 'type': 'BACKGROUND', 'citation': 'Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.'}, {'type': 'BACKGROUND', 'citation': "McBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062."}, {'type': 'BACKGROUND', 'citation': "Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris."}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).\n\nThis device was created as an alternative to blood sample, that have to be done in a medical laboratory.\n\nThe main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria of healthy volunteers:\n\n* Man or woman between 18 and 70 years\n* Body Mass Index \\>18 and \\<29\n* Absence of any acute pathology in the month preceding the study\n* To be affiliated or beneficiary of social security\n\nExclusion Criteria of healthy volunteers:\n\n* Pregnant, partutient or breastfeeding woman\n* Patient with Raynaud's syndrome\n* Person deprived of liberty by legal or administrative decision, person to a legal protection order\n* Deferral periods for other clinical studies\n* Annual threshold compensation attain for biomedical search participations\n\nInclusion Criteria of patients:\n\n* Man or woman between 18 and 80 years\n* Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)\n* Absence of any acute pathology in the month preceding the study\n* To be affiliated or beneficiary of social security\n\nExclusion Criteria of healthy patients:\n\n* Pregnant, partutient or breastfeeding woman\n* Patient with Raynaud's syndrome\n* Person deprived of liberty by legal or administrative decision, person to a legal protection order\n* Deferral periods for other clinical studies\n* Annual threshold compensation attain for biomedical search participations"}, 'identificationModule': {'nctId': 'NCT02843958', 'acronym': 'HEMOPTIC', 'briefTitle': 'Validation of a Portable Medical Device for Diagnostic in Vitro', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': "Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters", 'orgStudyIdInfo': {'id': '38RC14.008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy volunteers and patients under Vitamin K antagonist', 'interventionNames': ['Device: HEMOPTIC']}], 'interventions': [{'name': 'HEMOPTIC', 'type': 'DEVICE', 'armGroupLabels': ['Healthy volunteers and patients under Vitamin K antagonist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'UniversityHospitalGrenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'overallOfficials': [{'name': 'Jean-Luc Cracowski, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Hospital University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}