N/A
N=63
A Study to Evaluate Liver Stiffness With Shear Wave Elastography
Chronic Liver Disease · Advanced Fibrosis · Advanced Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT05097963 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Median Endoscopic Ultrasound (EUS) Shear Wave Elastography — 0.11 kPA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Ultrasound Shear Wave Elastography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Endoscopic Ultrasound (EUS) Shear Wave Elastography |
0.11 | — |
Summary
The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years of age who are undergoing EUS procedures.
- Subjects with history of chronic liver disease, advanced fibrosis or cirrhosis
- Subjects without any history of chronic liver disease
- Subjects who underwent MR elastography within six (6) months of enrollment will be eligible to participate in the study.
- Subjects able to give appropriate consent to the study or have an appropriate representative to do so.
Exclusion Criteria
- Subjects who may have MRI-incompatible metal implants/devices.
- Subjects with severe claustrophobia who may not tolerate MR elastography.
Data sourced from ClinicalTrials.gov (NCT05097963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.