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Ultrasound Elastography of Salivary Glands (ELSA)

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ClinicalTrials.gov Identifier: NCT02994797
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.

Condition or disease
sjögren Disease

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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elastometry of the Salivary Glands in Sicca Syndrome
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. salivary glands elastometry [ Time Frame: 1 day ]
    Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

male or female

more than 18 years old

consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome

Criteria

Inclusion Criteria:

  • Male or female
  • More than 18 years old
  • Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
  • Consent agreement

Exclusion Criteria:

  • No consent agreement
  • No sicca symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994797


Locations
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France
CHU Brest
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02994797     History of Changes
Other Study ID Numbers: ELSA
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Brest:
salivary glands
ultrasonography
elastometry
elastography
Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases