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

Conditions

• Disease of Liver and Bile Duct

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Oct 28, 2016

Status verified

Mar 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

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

Central Contacts

• Ajay Chaudhuri, MD
  716-907-1916
  [email protected]
• Andrew Talal, MD
  716-888-4737
  [email protected]

Locations (1)

Find similar trials in Buffalo, NY