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S-Shearwave Elastography for Assessment of Hepatic Fibrosis

NCT ID: NCT03047707

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Fibroses

Keywords

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ultrasound elastography S-Shearwave liver fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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S-Shearwave and TE

Group Type EXPERIMENTAL

S-Shearwave and TE

Intervention Type DIAGNOSTIC_TEST

S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.

Interventions

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S-Shearwave and TE

S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medison

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2017-0215

Identifier Type: -

Identifier Source: org_study_id