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

Not Applicable

Terminated

• Conditions: Otosclerosis

• Registration Number: NCT02435446
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-06
• Study Start: 2015-10-28
• Primary Completion: 2017-10-02
• Study Completion: 2017-10-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France