- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994797
Ultrasound Elastography of Salivary Glands (ELSA)
July 8, 2019 updated by: University Hospital, Brest
Elastometry of the Salivary Glands in Sicca Syndrome
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brest, France, 29200
- CHU Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary glands elastometry
Time Frame: 1 day
|
Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
December 13, 2016
First Posted (Estimate)
December 16, 2016
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Sjogren's Syndrome
Other Study ID Numbers
- ELSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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