NCT03047707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

February 8, 2017

Last Update Submit

June 27, 2018

Conditions

Liver Fibroses

Keywords

ultrasound elastographyS-Shearwaveliverfibrosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance to detect severe hepatic fibrosis (F3)

    Reference standard: histologic diagnosis or Transient elastography

    3 months

Secondary Outcomes (5)

  • Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes

    3 months

  • Intra-observer and inter-observer agreement of S-Shearwave measurements

    same day

  • Comparison of diagnostic performance: Shearwave vs. Transient elastography

    3 months

  • Usefulness of auto-profile function in S-Shearwave measurements

    3 months

  • Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis

    3 months

Study Arms (1)

S-Shearwave and TE

EXPERIMENTAL
Diagnostic Test: S-Shearwave and TE

Interventions

S-Shearwave and TEDIAGNOSTIC_TEST

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

S-Shearwave and TE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 9, 2017

Study Start

May 22, 2017

Primary Completion

April 24, 2018

Study Completion

May 31, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)