Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-25 @ 12:23 PM
Study NCT ID:
NCT05140395
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABTEST© Card Clinical Perfomance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'in situ used for near patient In vitro Medical device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between two reagents', 'timeFrame': '5 minutes', 'description': 'performance of pre transfusional controls with the referent reagent and the reagent in study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reagent Kits, Diagnostic'], 'conditions': ['Transfusion Reaction']}, 'descriptionModule': {'briefSummary': 'The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution', 'detailedDescription': 'The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': '66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.\n\n10 neonatal patients, background transfusion or Guthrie test.'}, 'identificationModule': {'nctId': 'NCT05140395', 'briefTitle': 'ABTEST© Card Clinical Perfomance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diagast'}, 'officialTitle': 'Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device', 'orgStudyIdInfo': {'id': 'CPSP_20-01_V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre transfusion control', 'description': 'Pre control transfusion with the referent reagent and the in study reagent', 'interventionNames': ['Diagnostic Test: ABTEST card']}], 'interventions': [{'name': 'ABTEST card', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card', 'armGroupLabels': ['Pre transfusion control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arras', 'country': 'France', 'facility': 'CH Arras', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}], 'overallOfficials': [{'name': 'Pascal Huchette, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Arras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diagast', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}