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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Completed
• CT.gov ID: NCT02896764
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arm: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ear Diseases	Device: Cone-beam CT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique A de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT02896764
• Other Study ID Numbers: MWS_2014_14
• First Posted: Sep 12, 2016
• Last Update Posted: Sep 12, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Ear Diseases

Study Results

No Results Posted as of Sep 12, 2016