Cone Beam and CT Scan for the Diagnosis of Otosclerosis (... | NCT02435446

Studies
Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)

NCT02435446

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Nov 4, 2020Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Otosclerosis

Interventions

Cone-beam computed tomography

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PROBLEM of inclusion

Expanded Access Info

Start Date

Oct 28, 2015Actual

Primary Completion Date

Oct 2, 2017Actual

Completion Date

Oct 2, 2017Actual

First Submitted Date

Apr 28, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 2015Estimated

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

Nov 2, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.

The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.

In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.

The results of the CBCT will be compared to those of the CT scan.

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eligible patients for cone-beam	Experimental	A cone-beam computed tomography will be offered to the patients undergoing a CT scan for the diagnosis and/or the pre-operative assessment of an otosclerosis, fulfilling the inclusion criterias and without any exclusion criteria.	Device: Cone-beam computed tomography

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis		1 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis

Exclusion Criteria:

Pregnancy
Breast feeding
Patient under a legal protection procedure
Patient denying to participate to the study
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

Condition Browse Module

MeSH Terms

ID	Term
D010040	Otosclerosis

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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