A Study to Evaluate Diagnostic Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® in Patients Scheduled for a Liver Biopsy
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kymberly Watt, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available