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Clinical Trials/NCT02896764
NCT02896764CompletedNot Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country61 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
Sensitivity of the cone-beam CT vs CT scan

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Eligible patients for cone-beam CT

Experimental

A cone-beam CT will be offered to the patient undergoing a CT scan of the middle ear

Intervention: Cone-beam CT (Device)

Outcomes

Primary Outcomes

Sensitivity of the cone-beam CT vs CT scan

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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