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

Last updated: March 27, 2025
Sponsor: State University of New York at Buffalo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

vibration controlled transient elastography (VCTE)

Clinical Study ID

NCT02897908
FibroScan
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Subjects with known, or suspected risk factors for steatosis (fat) or hepaticfibrosis

  • 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

Exclusion

Exclusion Criteria:

  • Patients less than 18 years of age

  • Pregnancy

  • Patients that do not want to be contacted for consideration in future researchstudies.

  • Patients diagnosed with ascites or peritoneal dialysis

  • Body mass index (BMI) ≥40

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: vibration controlled transient elastography (VCTE)
Phase:
Study Start date:
October 28, 2016
Estimated Completion Date:
December 31, 2026

Study Description

The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. 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.

Connect with a study center

  • Conventus Medical Office Building

    Buffalo, New York 14203
    United States

    Active - Recruiting

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