Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease

Not Applicable

Completed

• Conditions: Sjogren's Disease
• Interventions: Procedure: Ultrasound

• Registration Number: NCT02358213
• Lead Sponsor: University Hospital, Brest

Brief Summary

This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.

The reproducibility is measure on patients and not on recorded data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-06
• Status Verified: 2015-03
• Study Start: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Men and women from 18 to 80 years old
• Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
• The patients will have to be capable of adhering to the protocol of study and of having understood it.
• The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion

Exclusion Criteria

• Not cooperative patient and having refused to sign the informed consent.
• Patient incapable to understand the protocol, under guardianship or under guardianship.
• Unaffiliated patients to the Social Security.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure	Ultrasound	5 ultrasounds were done on 20 patients by 5 different sonographers

Primary Outcome Measures

Name	Time	Method
Reproducibility between experts	1 day	The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.

Secondary Outcome Measures

Name	Time	Method
Reproducibility by the sonographer	1 day	The sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts.