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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05214053
Other study ID # CHUBX 2021/21
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the Cone Beam and the multi-detector computed tomography for diagnosis and pre-operative evaluation of otosclerosis in patients addressed for conductive hearing loss with intact tympanic membrane. The study aims to show that the Cone Beam offers equivalent performances with lower radiation dosage in this indication


Description:

Otosclerosis is an inflammatory bone remodeling disorder of the otic capsule, characterized by spongiotic new bone formation, causing stamped ankylosis that can result in conductive hearing loss. Until now, the gold standard imaging technique for diagnosis and pre-operative evaluation of otosclerosis has been multi-detector computed tomography (MDCT). Cone Beam computed tomography is a relatively recent imaging modality. It is associated with a lower radiation dosage compared to MDCT, and a high spatial resolution that allows a more precise analysis of bone structures. During the last 15 years, its use has been increasingly common in odontology and craniofacial surgery. Several studies have already studied the utility of Cone Beam for temporal bone pathologies, including recent retrospective studies that showed satisfying diagnostic performances for otosclerosis. Up to now, very few prospective studies have compared those two imaging modalities for otosclerosis diagnosis and pre-operative evaluation. Therefore, those two exams will be performed in patients addressed to the hospital for conductive hearing loss with intact tympanic membrane. Thus, the performance of Cone Beam will be compared to MDCT, regarding the positive diagnosis of otosclerosis, the analysis of anatomical structures of the temporal bone for pre-operative evaluation, and also the benefits in terms of irradiation. The MDCTs will include fewer slices than routine MDCTs and will be centered on the area of interest, in order to keep a total radiation dosage smaller or equivalent to routine care


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (18 years and older) - Requiring radiological assessment for conductive hearing loss with intact tympanic membrane, confirmed by otoscopy and audiogram - Signed informed consent - Affiliated or beneficiary of health insurance Exclusion Criteria: - Absence of otosclerosis on the MDCT - History of middle ear surgery - Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control - Patient under legal protection

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cone Beam CT
Each patient will undergo a Cone Beam CT and a MDCT

Locations

Country Name City State
France CHU de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary False negative rate of Cone Beam for the diagnosis of otosclerosis False negative rate of Cone Beam for the diagnosis of otosclerosis, compared to MDCT (gold standard). 1 day
Secondary radiologic grades of otosclerosis Description of the radiologic grades of otosclerosis, based on Veillon's classification 1 day
Secondary extension to round window The parameter that will be assessed is the presence/absence of a bony hypodensity located on the round window bony structure .
CT will be considered as gold standard. CBCT may be less or equally accurate to detect this small hypodensity area structure
1 day
Secondary Existence of a bone canal around the labyrinthine portion of the facial nerve The parameter that will be assessed is the presence /absence of a bony structure covering the VIIth nerve a the level of the oval window.
CT will be considered as gold standard. CBCT may be less or equally accurate to detect this very thin bony structure , or even better in case of better detection
1 day
Secondary radiation dosage Comparison of radiation dosage between Cone Beam and MDCT 1 day
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