The EUS ShearWave Elastography Liver Fibrosis Study
NCT04115046 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52
Last updated 2021-09-09
Summary
The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.
Conditions
- Liver Fibroses
Interventions
- DEVICE
-
ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)
ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation.
- DEVICE
-
FibroScan
manufactured by Echosens
- DEVICE
-
ALOKA ARIETTA 850 -
manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software
Sponsors & Collaborators
-
Geisinger Clinic
collaborator OTHER -
Olympus Corporation of the Americas
lead INDUSTRY
Principal Investigators
-
David Diehl, MD · Geisinger Clinic
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-14
- Primary Completion
- 2021-04-26
- Completion
- 2021-05-17
- FDA Device
- Yes
Countries
- United States
Study Locations
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