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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435446
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease Intervention/treatment Phase
Otosclerosis Device: Cone-beam computed tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis
Actual Study Start Date : October 28, 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435446


Locations
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France
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, M.D.    0033148036431    lsalomon@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02435446    
Other Study ID Numbers: MWS_2015_18
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Otosclerosis
Ear Diseases
Otorhinolaryngologic Diseases