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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT02358213
Collaborator
(none)
21
Enrollment
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Official Title:
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: Procedure

5 ultrasounds were done on 20 patients by 5 different sonographers

Procedure: Ultrasound
Ultrasound examinations are done 5 times

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

  • Principal Investigator: ValĂ©rie DEVAUCHELLE, PUPH, Hospital Brest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT02358213
Other Study ID Numbers:
  • RB 14.133 ETREINTE
First Posted:
Feb 6, 2015
Last Update Posted:
Dec 16, 2015
Last Verified:
Mar 1, 2015
Keywords provided by University Hospital, Brest
reproductibility
Additional relevant MeSH terms:
Sjogren's Syndrome

Study Results

No Results Posted as of Dec 16, 2015