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Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear (ECCO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02896764
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Ear Diseases Device: Cone-beam CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2014
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eligible patients for cone-beam CT
A cone-beam CT will be offered to the patient undergoing a CT scan of the middle ear
Device: Cone-beam CT



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896764


Locations
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France
Fondation Ophtalmologique A de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02896764    
Other Study ID Numbers: MWS_2014_14
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases