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Ultrasound Elastography of Salivary Glands (ELSA)

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ClinicalTrials.gov Identifier: NCT02994797
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : July 11, 2017
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
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elastometry of the Salivary Glands in Sicca Syndrome
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

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


Contacts
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Contact: Sandrine Jousse-Joulin, MD 02-98-34-2768 sandrine.jousse-joulin@chu-brest.fr
Contact: Sandrine Jousse-Joulin, MD

Locations
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France
CHU Brest Recruiting
Brest, France, 29200
Contact: jousse-joulin sandrine, MD    0298347268    sandrine.jousse-joulin@chu-brest.fr   
Principal Investigator: jousse-joulin sandrine, MD         
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 11, 2017
Last Verified: July 2017
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