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

Recruiting

• Conditions: Disease of Liver and Bile Duct
• Interventions: Procedure: vibration controlled transient elastography (VCTE)

• Registration Number: NCT02897908
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-10-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Body mass index (BMI) ≥40

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver fibrosis and steatosis	vibration controlled transient elastography (VCTE)	measurements of liver fibrosis and steatosis will be obtained using Vibration controlled transient elastography FDA approved device- FibroScan for the purpose of building a data base of potential subjects for future research.

Primary Outcome Measures

Name	Time	Method
measurement of fibrosis in patients with varying degrees of liver disease	10 years	single event per patient with liver disease to measure degree of fibrosis concentration

Secondary Outcome Measures

Name	Time	Method
measurement of liver fat in patients with varying degrees of liver disease	10 years	single event per patient with liver disease to measure degree of fat concentration

Trial Locations

Locations (1)

Conventus Medical Office Building; 🇺🇸 Buffalo, New York, United States