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

December 15, 2015 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Procedure
5 ultrasounds were done on 20 patients by 5 different sonographers
Procedure: Ultrasound
Ultrasound examinations are done 5 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility between experts
Time Frame: 1 day
The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility by the sonographer
Time Frame: 1 day
The sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Valérie DEVAUCHELLE, PUPH, Hospital Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB 14.133 ETREINTE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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