ClinicalTrials.gg
CompletedNCT02896764ECCO1Updated Sep 12, 2016

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

An interventional study of Cone-beam CT in Ear Diseases, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-12.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ear Diseases

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03

In context

Ear Diseases

48 studies on the registry are indexed under Ear Diseases; 10 are open to participants now.

This study's enrollment of 61 is close to the median of 61 across 37 interventional studies indexed under Ear Diseases.

Browse Ear Diseases studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
  • Patient under a legal protection procedure
  • Lack of affiliation to a social security system
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

Interventions

  • DeviceCone-beam CT
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 minute

07

Study locations

1 site
  • Fondation Ophtalmologique A de Rothschild
    Paris, 75019, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014 and a primary completion of Feb 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2016
First posted
Sep 12, 2016
Start
Oct 2014
Primary completionActual
Feb 2015
Last update
Sep 12, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02896764
Responsible party
Sponsor
First posted
Sep 12, 2016
Start date
Oct 2014
Primary completion
Feb 2015
Last update
Sep 12, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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