A Study to Evaluate Diagnostic Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® in Patients Scheduled for a Liver Biopsy

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-009735
    Sponsor Protocol Number: 16-009735

About this study

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Patients at least 18 years old
  • Patients or their surrogates must be able to give written informed consent
  • Patients referred to clinically-indicated liver biopsy, of any liver disease etiology, and including liver transplant

Exclusion Criteria:

  • Unable or unwilling to provide written informed consent
  • Pregnant women
  • Patients with active implantable medical device (e.g. pacemaker or defibrillator)

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kymberly Watt, M.D.

Open for enrollment

Contact information:

Tim Gunneson P.A.-C.

(507)284-6288

Gunneson.Timothy@mayo.edu