S-Shearwave Elastography for Assessment of Hepatic Fibrosis | NCT03047707

Studies
S-Shearwave Elastography for Assessment of Hepatic Fibrosis

NCT03047707

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 29, 2018Actual

Enrollment

634Actual

Phase

Not Applicable

Conditions

Liver Fibroses

Interventions

S-Shearwave and TE

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2017Actual

Primary Completion Date

Apr 24, 2018Actual

Completion Date

May 31, 2018Actual

First Submitted Date

Feb 8, 2017

First Submission Date that Met QC Criteria

Feb 8, 2017

First Posted Date

Feb 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2018

Last Update Posted Date

Jun 29, 2018Actual

Name	Class
Samsung Medison	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

634Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S-Shearwave and TE	Experimental		Diagnostic Test: S-Shearwave and TE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-Shearwave and TE	Diagnostic Test	S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.	S-Shearwave and TE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic performance to detect severe hepatic fibrosis (F3)	Reference standard: histologic diagnosis or Transient elastography	3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong Min Lee, M.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D005355	Fibrosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided