Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

NCT05214053 | Terminated

• 1 other identifier: CHUBX 2021/21
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Otosclerosis

Keywords

Otosclerosis; Cone Beam; Conductive hearing loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• radiologic grades of otosclerosis

  1 day

• extension to round window

  1 day

• Existence of a bone canal around the labyrinthine portion of the facial nerve

  1 day

• radiation dosage

  1 day

Study Arms (1)

Cone Beam CT

EXPERIMENTAL

Each patient will undergo a Cone Beam CT and a MDCT

Device: Cone Beam CT

Interventions

Cone Beam CT DEVICE

Each patient will undergo a Cone Beam CT and a MDCT

Cone Beam CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Otosclerosis; Hearing Loss, Conductive

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 28, 2022
• Study Start: January 18, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)