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

NCT ID: NCT02358213

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Sjogren's Disease

Keywords

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reproductibility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Procedure

5 ultrasounds were done on 20 patients by 5 different sonographers

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

Ultrasound examinations are done 5 times

Interventions

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Ultrasound

Ultrasound examinations are done 5 times

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie DEVAUCHELLE, PUPH

Role: PRINCIPAL_INVESTIGATOR

Hospital Brest

Other Identifiers

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RB 14.133 ETREINTE

Identifier Type: -

Identifier Source: org_study_id