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

Sjogren's Disease Clinical Trial

— ETREINTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358213
• Other study ID #: RB 14.133 ETREINTE
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: December 15, 2015
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Sjogren's Disease
• Sjogren's Syndrome

Intervention

Procedure:
• Ultrasound
Ultrasound examinations are done 5 times

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility between experts	The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.	1 day	No
Secondary	Reproducibility by the sonographer	The sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts.	1 day	No