NCT02358213

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 16, 2015

Status Verified

March 1, 2015

Enrollment Period

Same day

First QC Date

January 26, 2015

Last Update Submit

December 15, 2015

Conditions

Sjogren's Disease

Keywords

reproductibility

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Reproducibility by the sonographer

    1 day

Study Arms (1)

Procedure

OTHER

5 ultrasounds were done on 20 patients by 5 different sonographers

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

Ultrasound examinations are done 5 times

Procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Valérie DEVAUCHELLE, PUPH

    Hospital Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 6, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-03