sjögren Disease Clinical Trial
— ELSAOfficial title:
Elastometry of the Salivary Glands in Sicca Syndrome
| NCT number | NCT02994797 |
| Other study ID # | ELSA |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2016 |
| Est. completion date | April 2018 |
| Verified date | August 2018 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 78 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Brest | Brest |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | salivary glands elastometry | Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second | 1 day |