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

NCT ID: NCT02435446

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2017-10-02

Brief Summary

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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

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Conditions

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Otosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cone-beam computed tomography

Intervention Type DEVICE

Cone-beam computed tomography

Interventions

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Cone-beam computed tomography

Cone-beam computed tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MWS_2015_18

Identifier Type: -

Identifier Source: org_study_id