Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT02901093
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Prosthesis Penetration With Conebeam in Otosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010040', 'term': 'Otosclerosis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-23', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'location of the medial tip of the prosthesis within the vestibule', 'timeFrame': '1 day after surgery', 'description': 'computerized tomography with cone beam'}, {'measure': 'intravestibular length of the prosthesis', 'timeFrame': '1 day after surgery', 'description': 'computerized tomography with cone beam'}, {'measure': 'incidence of postoperative pneumolabyrinth', 'timeFrame': '1 day after surgery', 'description': 'computerized tomography with cone beam'}, {'measure': 'incidence of vertigo', 'timeFrame': '1 day after surgery', 'description': 'clinical assessment'}, {'measure': 'incidence of nystagmus', 'timeFrame': '1 day after surgery', 'description': 'clinical assessment'}, {'measure': 'change in pure-tone bone conduction hearing thresholds', 'timeFrame': 'between baseline and 1 day after surgery', 'description': 'measured at 250, 500, 1000, 2000, 3000, 4 000 Hz'}, {'measure': 'Pure-tone audiometry', 'timeFrame': '7 days, 1 month and 3 months after surgery'}, {'measure': 'bone conduction hearing thresholds', 'timeFrame': '7 days, 1 month and 3 months after surgery'}, {'measure': 'Speech Discrimination', 'timeFrame': 'baseline, 1 month and 3 months after surgery', 'description': 'audiometry: Speech Discrimination Score at a standard presentation level of 60 decibels (SDS60) expressed in percentages'}, {'measure': 'Speech Reception', 'timeFrame': 'baseline, 1 month and 3 months after surgery', 'description': 'audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB'}]}, 'conditionsModule': {'keywords': ['Stapes surgery', 'Sensorineural complications', 'Inner ear', 'Imaging', 'Cone Beam CT'], 'conditions': ['Otosclerosis']}, 'referencesModule': {'references': [{'pmid': '28068300', 'type': 'RESULT', 'citation': 'Vandevoorde A, Williams MT, Ukkola-Pons E, Daval M, Ayache D. Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome. Otol Neurotol. 2017 Feb;38(2):168-172. doi: 10.1097/MAO.0000000000001306.'}]}, 'descriptionModule': {'briefSummary': 'Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.\n\nUnfortunately, there is very little data in an unselected series of uneventful patients.\n\nThe aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing stapes surgery for otosclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\>= 18 years old\n* patients undergoing stapes surgery for otosclerosis\n\nExclusion Criteria:\n\n* patient's refusal to participate in the study\n* patient under legal protection\n* no medical insurance coverage\n* pregnant or breast feeding patient"}, 'identificationModule': {'nctId': 'NCT02901093', 'acronym': 'QUIPROCOS', 'briefTitle': 'Quantification of Prosthesis Penetration With Conebeam in Otosclerosis', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome', 'orgStudyIdInfo': {'id': 'DAE_2014_15'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}