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

Primary Purpose

Otosclerosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cone-beam computed tomography
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ophtalmologique A de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eligible patients for cone-beam

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis

Secondary Outcome Measures

Full Information

First Posted
April 28, 2015
Last Updated
November 2, 2020
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02435446
Brief Title
Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)
Acronym
TACOS
Official Title
Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
PROBLEM of inclusion
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
October 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otosclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eligible patients for cone-beam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cone-beam computed tomography
Intervention Description
Cone-beam computed tomography
Primary Outcome Measure Information:
Title
Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondation Ophtalmologique A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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