Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-17 @ 5:10 AM
Study NCT ID:
NCT06497335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy between SpHb measure and Hemoglobin level on the post operative blood sample', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'level of immediate post operative SpHb measure compared to blood hemoglobin measure, ROC curve'}], 'secondaryOutcomes': [{'measure': 'Spearman correlation coefficient', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'correlation between Laboratory Hb and SpHb measure'}, {'measure': 'Kappa coefficient', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'correlation between SpHb measure and correct classification of patients anemia vs no anemia'}, {'measure': 'Intra class correlation coefficient', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'correlation between Laboratory measurement and SpHb measurement'}, {'measure': 'Subgroup analysis of ROC curve (classes of age 18-30; 30-40; 40-50; >50)', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of ROC curve areas in subgroups'}, {'measure': 'impact of body temperature on accuracy of SpHb', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of ROC curve areas in subgroups of temperature (classes of temperature : \\<35; 35-36; \\>36)'}, {'measure': 'impact of perfusion index on accuracy of SpHb', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of ROC curve areas in subgroups of perfusion index (good or low perfusion index)'}, {'measure': 'impact of leght between SpHb measurement and laboratory Hb measurement on accuracy', 'timeFrame': 'at 2 and 8 months after establishment of PBM protocol', 'description': 'comparison of ROC curve areas in subgroups of lenght in days between SpHb measurement and Laboratory Hb measurement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post operative screening', 'anemia', 'iron deficiency', 'diagnosis'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': "Non invasive Hemoglobin monitoring by SpHb device had been developed to assess Hemoglobin level during hemorrhagic surgery. It's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. This study aims to valid these finding on a cohort of post operative patients from gynaecological department."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'population of gynecological surgical department', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy\n* \\> 18 years\n\nExclusion Criteria:\n\n* non french speaker\n* being under a legal individual protection measure\n* not being able to consent\n* being opposed to data collection'}, 'identificationModule': {'nctId': 'NCT06497335', 'acronym': 'SpHb_gyneco', 'briefTitle': 'Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis: a Validation Study in Gynecological Surgery Department of Angers 's University Hospital", 'orgStudyIdInfo': {'id': '24_0206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non invasive hemoglobin measure', 'type': 'DIAGNOSTIC_TEST', 'description': 'non invasive hemoglobin measure'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sigismond Lasocki', 'role': 'CONTACT', 'email': 'SiLasocki@chu-angers.fr', 'phone': '02/41/35/36/37', 'phoneExt': '+33'}, {'name': 'Elise Houssin', 'role': 'CONTACT', 'email': 'DRCI-Promotion-Interne@chu-angers.fr', 'phone': '02 41 35 36 37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sigismond Lasocki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}