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Quantitative Evaluation of the Progression of Liver Disease, Using ShearWaveTM

Sponsor
Baylor Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02070315
Collaborator
(none)
1,000
Enrollment
1
Location
105
Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To obtain a quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine.

    To compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in post-liver transplantation patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quantitative Evaluation of Liver Disease With Liver and Kidney Elastography Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine
    Study Start Date :
    Feb 1, 2012
    Anticipated Primary Completion Date :
    Nov 1, 2020
    Anticipated Study Completion Date :
    Nov 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Shearwave Elastography Ultrasound [1 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • Any person unable to provide an informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor University Medical Center Dallas Texas United States 75246

    Sponsors and Collaborators

    • Baylor Research Institute

    Investigators

    • Principal Investigator: James Trotter, MD, Baylor Health Care System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT02070315
    Other Study ID Numbers:
    • 012-011
    First Posted:
    Feb 25, 2014
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Baylor Research Institute
    heart failure
    liver failure
    post liver transplant
    Additional relevant MeSH terms:
    Liver Diseases
    Heart Failure

    Study Results

    No Results Posted as of Feb 21, 2020