Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear

Not Applicable

Completed

• Conditions: Ear Diseases

• Registration Number: NCT02896764
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays are divergent, forming a cone.

As a result, this technique is less irradiating that the scanner. The purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-02
• Status Verified: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-12
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Adult patient
• Indication of a CT scan of the ear
• Written and signed informed consent by the patient to participate in the study

Exclusion Criteria

• Pregnancy
• Breast feeding
• Patient under a legal protection procedure
• Lack of affiliation to a social security system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity of the cone-beam CT vs CT scan	1 minute	Correlation coefficient measuring the concordance for a given radiologist, between the number of anatomical structures of the ear viewed by the cone beam CT and the CT scanner on a total of 24 studied structures

Trial Locations

Locations (1)

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France