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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02435446
Other study ID # MWS_2015_18
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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