Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-30 @ 2:33 PM
Study NCT ID:
NCT05799404
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stapes Footplate Thickness Measured With UHR-CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010040', 'term': 'Otosclerosis'}, {'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010031', 'term': 'Otitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stapes footplate thickness in mm in the stapes axial plane', 'timeFrame': 'october 2020-october 2022', 'description': 'stapes footplate thickness measured with a digital caliper on our PACS system with the accuracy of a tenth of a millimetre, under the anterior crus of the stapes, under the posterior crus of the stapes, and at its midpoint, in the stapes axial plane and in the lateral semi circular canal plane, to compare both values and find out wich one is the most pertinent'}], 'secondaryOutcomes': [{'measure': 'interobserver variability', 'timeFrame': 'october 2020-october 2022', 'description': 'interobserver variability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultra high resolution', 'ct', 'stapes', 'footplate', 'otosclerosis', 'otitis media'], 'conditions': ['Otosclerosis', 'Otitis Media']}, 'referencesModule': {'references': [{'pmid': '32700991', 'type': 'BACKGROUND', 'citation': 'Akazawa Y, Ganaha A, Higa T, Kondo S, Oyakawa Y, Hirakawa H, Suzuki M, Yamashiro T. Measurement of stapes footplate thickness in otosclerosis by ultra-high-resolution computed tomography. Acta Otolaryngol. 2020 Nov;140(11):899-903. doi: 10.1080/00016489.2020.1788225. Epub 2020 Jul 23.'}, {'pmid': '34058698', 'type': 'BACKGROUND', 'citation': 'Tang R, Yin H, Wang Z, Zhang Z, Zhao L, Zhang P, Li J, Zhao P, Lv H, Zhang L, Yang Z, Wang Z. Stapes visualization by ultra-high resolution CT in cadaveric heads: A preliminary study. Eur J Radiol. 2021 Aug;141:109786. doi: 10.1016/j.ejrad.2021.109786. Epub 2021 May 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.', 'detailedDescription': 'Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultra high resolution CT of the temporal bone available\n\nExclusion Criteria:\n\n* previous surgery'}, 'identificationModule': {'nctId': 'NCT05799404', 'briefTitle': 'Stapes Footplate Thickness Measured With UHR-CT', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Stapes Footplate Thickness Measured With UHR-CT', 'orgStudyIdInfo': {'id': 'N°3-RCB/EUDRACT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'otosclerosis', 'description': 'otosclerosis patients', 'interventionNames': ['Diagnostic Test: ultra-high resolution CT']}, {'label': 'chronic otitis media', 'description': 'otitis media with middle ear opacities', 'interventionNames': ['Diagnostic Test: ultra-high resolution CT']}, {'label': 'controls', 'description': 'sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation', 'interventionNames': ['Diagnostic Test: ultra-high resolution CT']}], 'interventions': [{'name': 'ultra-high resolution CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'stapes footplate thickness measurement', 'armGroupLabels': ['chronic otitis media', 'controls', 'otosclerosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'romain gillet, MD', 'role': 'CONTACT', 'email': 'r.gillet@chru-nancy.fr', 'phone': '003383851811'}], 'overallOfficials': [{'name': 'romain gillet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSK Radiologist', 'investigatorFullName': 'GILLET Romain', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}