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

NCT02897908 | Recruiting

• 1 other identifier: FibroScan
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease of Liver and Bile Duct

Outcome Measures

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

  10 years

Secondary Outcomes (1)

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

  10 years

Study Arms (1)

liver fibrosis and steatosis

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.

Procedure: vibration controlled transient elastography (VCTE)

Interventions

vibration controlled transient elastography (VCTE) PROCEDURE

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.

Also known as: fibroscan

liver fibrosis and steatosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Kaleida Health: collaborator

Study Sites (1)

Conventus Medical Office Building

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases

Central Study Contacts

Ajay Chaudhuri, MD

CONTACT

716-907-1916; achaudhu@buffalo.edu

Andrew Talal, MD

CONTACT

716-888-4737; ahtalal@buffalo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2016
• First Posted: September 13, 2016
• Study Start: October 28, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

US (1)