Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorState University of New York at Buffalo

About this trial

The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis

Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring

Subjects who have other known liver diseases ie: HCV

Disqualifiers

Patients less than 18 years of age

Pregnancy

Patients that do not want to be contacted for consideration in future research studies.

Patients diagnosed with ascites or peritoneal dialysis

Trial population

* Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis * Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring * Subjects who have other known liver diseases ie: hepatitis C virus (HCV)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • vibration controlled transient elastography (VCTE)

    Procedure/Surgery

    Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from a given VCTE exam is the median value of at least 10 successful measurements. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: liver fibrosis and steatosis1 intervention

Trial outcomes

Primary outcomes

1

measurement of fibrosis in patients with varying degrees of liver disease

single event per patient with liver disease to measure degree of fibrosis concentration

Time frame
10 years

Secondary outcomes

1

measurement of liver fat in patients with varying degrees of liver disease

single event per patient with liver disease to measure degree of fat concentration

Time frame
10 years

Other outcomes

Sponsors and contacts

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