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

November 2, 2020 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eligible patients for cone-beam
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
Cone-beam computed tomography

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2015

Primary Completion (Actual)

October 2, 2017

Study Completion (Actual)

October 2, 2017

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWS_2015_18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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