NCT02896764

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 7, 2016

Last Update Submit

September 7, 2016

Conditions

Ear Diseases

Outcome Measures

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

    1 minute

Study Arms (1)

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

Device: Cone-beam CT

Interventions

Cone-beam CTDEVICE
Eligible patients for cone-beam CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Breast feeding
  • Patient under a legal protection procedure
  • Lack of affiliation to a social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Ear Diseases

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

FR(1)