The EUS ShearWave Elastography Liver Fibrosis Study

NCT04115046 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2021-09-09

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115046 on ClinicalTrials.gov