NCT02070315

Brief Summary

Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

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

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

January 27, 2026

Status Verified

August 1, 2022

Enrollment Period

10.2 years

First QC Date

January 8, 2013

Last Update Submit

January 26, 2026

Conditions

Liver DiseaseHeart Failure

Keywords

heart failureliver failurepost liver transplant

Outcome Measures

Primary Outcomes (1)

  • Shearwave Elastography Ultrasound

    Patients will have a scan performed at their regularly scheduled clinic visits.

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants will be from Liver Consultants of Texas patient population

You may qualify if:

  • Males and Females over the age of 18
  • Patients of Liver Consultant's of Texas Dallas office, with chronic liver disease or liver transplant patient seen in Liver Transplant Clinic
  • Patients diagnosed with heart failure

You may not qualify if:

  • \- Any person unable to provide an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Liver DiseasesHeart FailureLiver Failure

Condition Hierarchy (Ancestors)

Digestive System DiseasesHeart DiseasesCardiovascular DiseasesHepatic Insufficiency

Study Officials

  • James Trotter, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

February 25, 2014

Study Start

February 1, 2012

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

January 27, 2026

Record last verified: 2022-08

Locations

US(1)