CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Shear Wave Sonoelastographydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01747772
NCT01747772N/ACompleted
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Evaluate the Utility of Shear Wave Sonoelastography as a Tool to Measure Liver Fibrosis Grade

Massachusetts General Hospital·interventional·Posted Dec 12, 2012·Updated Jun 14, 2017

In Brief

A clinical study evaluating Shear Wave Sonoelastography for Chronic Liver Disease and 4 related conditions. Completed, enrolled 180 participants across 1 site.

Detailed Summary

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal liver biopsy as part of their routine clinical care 2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis 3. To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Liver Disease, Non-Alcoholic Fatty Liver Disease, Hepatitis C Virus (HCV) Coinfection, Hepatitis B Virus (HBV), Drug-Induced Liver Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2012
Enrollment StartFeb 1, 2010
Primary CompletionFeb 14, 2014
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.6 years ago

Interventions

Shear Wave Sonoelastographydevice

Shear Wave sonoelastography (SWE) as an ultrasound technique to measure liver fibrosis was performed on patients scheduled for non-focal liver biopsy. Results were compared with pathological score from liver biopsy.