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S-Shearwave Elastography for Assessment of Hepatic Fibrosis

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Seoul National University

Status

Completed

Conditions

Liver Fibroses

Treatments

Diagnostic Test: S-Shearwave and TE

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03047707
SNUH-2017-0215

Details and patient eligibility

About

The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.

Enrollment

634 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
  • Signed informed consent

Exclusion criteria

  • Acute hepatitis or bile duct obstruction
  • Serum ALT> 5 times the upper limit of normal within 3 months
  • s/p Rt. hemihepatectomy
  • s/p liver transplantation
  • Large mass or infiltrative lesion in the right lobe of the liver

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

634 participants in 1 patient group

S-Shearwave and TE
Experimental group
Treatment:
Diagnostic Test: S-Shearwave and TE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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