Interest of the Cone-beam Computed Tomography in the Imag... | NCT02896764

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

NCT02896764

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Sep 12, 2016Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Ear Diseases

Interventions

Cone-beam CT

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Not provided

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2016

Last Update Posted Date

Sep 12, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cone-beam CT	Device		Eligible patients for cone-beam CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique A de Rothschild		Paris		75019	France

ID	Term
D004427	Ear Diseases

ID	Term
D010038	Otorhinolaryngologic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D054893	Cone-Beam Computed Tomography

Ancestor Terms

ID	Term
D014057	Tomography, X-Ray Computed
D014056	Tomography, X-Ray
D011859	Radiography
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided