About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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)
Trial design
Case-only
Prospective
Treatments tested in this trial
vibration controlled transient elastography (VCTE)
Procedure/SurgeryOnce 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.
Treatment groups
Trial outcomes
Primary outcomes
measurement of fibrosis in patients with varying degrees of liver disease
single event per patient with liver disease to measure degree of fibrosis concentration
Secondary outcomes
measurement of liver fat in patients with varying degrees of liver disease
single event per patient with liver disease to measure degree of fat concentration
Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
Kaleida Health
Collaborator