Back to resultsInterest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear (ECCO1)
Primary Purpose
Ear Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cone-beam CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Ear Diseases
Eligibility Criteria
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
Sites / Locations
- Fondation Ophtalmologique A de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eligible patients for cone-beam CT
Arm Description
A cone-beam CT will be offered to the patient undergoing a CT scan of the middle ear
Outcomes
Primary Outcome Measures
Sensitivity of the cone-beam CT vs CT scan
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 Outcome Measures
Full Information
NCT ID
NCT02896764
First Posted
September 7, 2016
Last Updated
September 7, 2016
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02896764
Brief Title
Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear
Acronym
ECCO1
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eligible patients for cone-beam CT
Arm Type
Experimental
Arm Description
A cone-beam CT will be offered to the patient undergoing a CT scan of the middle ear
Intervention Type
Device
Intervention Name(s)
Cone-beam CT
Primary Outcome Measure Information:
Title
Sensitivity of the cone-beam CT vs CT scan
Description
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
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation Ophtalmologique A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear
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