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

Otosclerosis Clinical Trial

— TACOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02435446
• Other study ID #: MWS_2015_18
• Status: Terminated
• Phase: N/A
• Start date: October 28, 2015
• Est. completion date: October 2, 2017

Study information

• Verified date: November 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: October 2, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otosclerosis

Intervention

Device:
• Cone-beam computed tomography
Cone-beam computed tomography

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis		1 minute