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NCT Number: NCT02897908

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

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.

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Key information

Conditions

Disease of Liver and Bile Duct Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Conventus Medical Office Building

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Ajay Chaudhuri, MD

CONTACT

[email protected]

716-907-1916

Ajay Chaudhuri, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: fibroscan

Primary outcomes

  1. measurement of fibrosis in patients with varying degrees of liver disease

    Time frame: 10 years

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

Secondary outcomes

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

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Chaudhuri, MD

CONTACT

[email protected]

716-907-1916

Andrew Talal, MD

CONTACT

[email protected]

716-888-4737

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Kaleida Health

Registry information

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Sep 13, 2016
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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