Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 7:54 AM
Study NCT ID:
NCT01235806
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2010-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI and radiography interpretation items', 'timeFrame': 'The day of the scaphoid fracture', 'description': 'comparaison between MRI and radiography interpretation items'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['scaphoid', 'MRI', 'ESAOTE'], 'conditions': ['Scaphoid Bone Fracture Suspicion']}, 'descriptionModule': {'briefSummary': 'The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.\n\nThe aim of our project is to study its interest in diagnosis of scaphoid fractures.\n\nConventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.\n\nYet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.\n\nAlternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.\n\nMRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.\n\nThe few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.\n\nFinally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.\n* Major patient who signed the informed consent form.\n* Patient affiliated to French national health and pensions organization. NON INCLUSION\n* MRI contraindication.\n* No pain.\n* No traumatic antecedent.\n* Pregnant or suckler women.\n* Patient under a guardianship or a trusteeship\n* Patient deprived of liberty consequently to a judiciary procedure\n* Patient holding a pace-maker\n* Patient holding a foreign body or ferromagnetic prosthetic material.'}, 'identificationModule': {'nctId': 'NCT01235806', 'briefTitle': 'Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.', 'orgStudyIdInfo': {'id': '07-CPR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI', 'description': 'MRI of the scaphoid bone fracture suspicion', 'interventionNames': ['Radiation: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'RADIATION', 'description': 'MRI of the scaphoid bone fracture suspicion', 'armGroupLabels': ['MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Nicolas AMORETTI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical and interventionnal Imaging Unit, Nice University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}