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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02358213
Acronym
ETREINTE
Enrollment
21
Registered
2015-02-06
Start date
2015-03-31
Completion date
2015-03-31
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Disease

Keywords

reproductibility

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.

Interventions

PROCEDUREUltrasound

Ultrasound examinations are done 5 times

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility between experts1 dayThe outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.

Secondary

MeasureTime frameDescription
Reproducibility by the sonographer1 dayThe sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026