Recruiting

Liver Screening

Sponsor:

State University of New York at Buffalo

Code:

NCT02897908

Conditions

Disease of Liver and Bile Duct

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

vibration controlled transient elastography (VCTE)

Study Details

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

Study ID

NCT02897908

Start date

Oct 28, 2016

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

vibration controlled transient elastography (VCTE)

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.

Primary outcome measure

  • measurement of fibrosis in patients with varying degrees of liver disease [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Ajay Chaudhuri, MD

716-907-1916achaudhu@buffalo.edu

Andrew Talal, MD

716-888-4737ahtalal@buffalo.edu

Locations

Conventus Medical Office Building

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ajay Chaudhuri, MD

716-907-1916achaudhu@buffalo.edu

Principal Investigator:

Ajay Chaudhuri, MD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-22.