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Comparison of Smart-Shear Wave Elastography and Transient Elastography

NCT02569567 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2015-11-17

No results posted yet for this study

Summary

The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.

Conditions

  • Fibrosis, Liver

Interventions

PROCEDURE

Smart-Shear Wave(SSW) imaging

1. All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator. 2. The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction. 3. Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement.

PROCEDURE

Transient elastography(TE)

1. Using the M probe in patients with BMI \<30 kg/m2. 2. Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface. 3. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • So Yeon Kim, Dr · Asan Medical Center

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • South Korea

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 NCT02569567 on ClinicalTrials.gov