Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05214053
Status:
TERMINATED
Last Update Posted:
2022-10-24
First Post:
2021-12-01
Brief Title:
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONBEAM OTO
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None