Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 10:43 PM
Study NCT ID:
NCT05882435
Status:
UNKNOWN
Last Update Posted:
2023-05-31
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009938', 'term': 'Organizations'}], 'ancestors': [{'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic error rate', 'timeFrame': "Through patient's discharge from the emergency department, an average of 1 day", 'description': "A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED.\n\nA diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED."}], 'secondaryOutcomes': [{'measure': 'Time between x-ray and first diagnostic', 'timeFrame': "Through patient's discharge from the emergency department, an average of 1 day", 'description': 'Time between x-ray and first diagnostic, either by the emergency physician or by the radiologist'}, {'measure': 'Time between x-ray and first diagnostic by the emergency physician', 'timeFrame': "Through patient's discharge from the emergency department, an average of 1 day", 'description': 'Time between x-ray and first diagnostic by the emergency physician in the patient medical file'}, {'measure': 'Time between x-ray and final diagnostic by the emergency physician', 'timeFrame': '30 days', 'description': 'Time between x-ray and final diagnostic by the emergency physician in the patient medical file. A diagnostic will be considered as final if the same as the consensus one'}, {'measure': 'Rate of X-rays interpretation by radiologist without delay', 'timeFrame': '1 hour', 'description': 'Rate of X-rays interpretation by radiologist without delay (i.e within 1 hour)'}, {'measure': 'Number of all radiological exam per patient prescribed by the ED', 'timeFrame': "Through patient's discharge from the emergency department, an average of 1 day", 'description': 'Number of all radiological exam per patient prescribed by the ED (MRI, scanner, x-rays, echography)'}, {'measure': 'Number of X-rays with a report by a radiologist at 30 days', 'timeFrame': '30 days', 'description': 'Number of X-rays with a report by a radiologist at 30 days'}, {'measure': 'Time spent in the ED by the patient', 'timeFrame': "Through patient's discharge from the emergency department, an average of 1 day", 'description': 'Time spent in the ED by the patient'}, {'measure': 'Number of patients invited to come back in the ED', 'timeFrame': '30 days', 'description': 'Number of patients invited to come back in the ED'}, {'measure': '30 days morbidity', 'timeFrame': '30 days', 'description': 'New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit'}, {'measure': 'Total cost from the hospital viewpoint', 'timeFrame': '30 days', 'description': 'Total cost from the hospital viewpoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Fracture']}, 'descriptionModule': {'briefSummary': 'The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone standard X-rays prescibed by the ED.', 'detailedDescription': '"The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone radiographs prescibed by the ED.\n\nThe primary objective of the organizational study is to evaluate, compared to the current organization for the interpretation of standard bone radiographs requested by the ED, the impact of an organization incorporating the Milvue solution, on the reduction of the patient diagnostic error rate.\n\nA cost-consequence study is carried out, comparing from the point of view of the community (production costs according to the HAS recommendations), the radiological diagnosis within the framework of an organization with the Milvue solution, to that within the framework of the current organization without the use of the Milvue solution.\n\nThe economic study will follow the scheme of the organizational study, comparing the periods with and without the Milvue solution and analyzing the costs and consequences, by period and by patient.\n\nThis is an open-label randomized cluster multiple period cross-over study with 6 alternate periods (3 with AI, 3 with usual organization) of 1 month in each ED. The choice of the intervention for the first period will be randomized."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All adult referred by the ED for a conventional X-rays of all or part of the appendicular skeleton and/or pelvis and/or costal gril\n2. Not opposed to participate"'}, 'identificationModule': {'nctId': 'NCT05882435', 'acronym': 'IMMEDIAT', 'briefTitle': 'Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department', 'orgStudyIdInfo': {'id': '21OLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Organization', 'description': "X-rays are done in the radiology department and the images are made available to emergency physicians without waiting for the radiologist's report, which is usually done on a delayed basis."}, {'type': 'OTHER', 'label': 'Organization with AI', 'description': 'X-rays are done in the radiology department and the images are made available to emergency physicians with the AI interpretation. X-rays flagged by IA as anormal or suspicious will be reviewed without delay by the radiologist, non-flagged X-rays will be reviewed by radiologists on a delayed basis.', 'interventionNames': ['Other: Organization with AI']}], 'interventions': [{'name': 'Organization with AI', 'type': 'OTHER', 'description': 'X-rays are done in the radiology department and the images are made available to emergency physicians with the AI interpretation. X-rays flagged by IA as anormal or suspicious will be reviewed without delay by the radiologist, non-flagged X-rays will be reviewed by radiologists on a delayed basis.', 'armGroupLabels': ['Organization with AI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ANNE Miquel', 'role': 'CONTACT'}], 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier LUCIDARME, MD, PhD', 'role': 'CONTACT', 'email': 'olivier.lucidarme@aphp.fr', 'phone': '01 42 17 63 22'}, {'name': 'Imene HADDADOU, clinical project manager', 'role': 'CONTACT', 'email': 'imene.haddadou@aphp.fr', 'phone': '01 42.16.77. 14'}], 'facility': 'Hôpital Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'HELENE GOULET', 'role': 'CONTACT'}], 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Olivier LUCIDARME, MD, PhD', 'role': 'CONTACT', 'email': 'olivier.lucidarme@aphp.fr', 'phone': '01 42 17 63 22'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}