NCT02897908 · State University of New York at Buffalo
Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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 measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Buffalo, New York
Collaborators
Kaleida Health
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations