Disease of Liver and Bile DuctNCT02897908
Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
An observational study of Disease of Liver and Bile Duct, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease of Liver and Bile Duct
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2016to Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Conventus Medical Office Building
Buffalo, New York, 14203
Ajay Chaudhuri, MD, 716-907-1916, achaudhu@buffalo.edu
Ajay Chaudhuri, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Disease of Liver and Bile Duct
- Being tested
- vibration controlled transient elastography (VCTE)
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration controlled transient elastography (VCTE)Procedure or surgery
Also called fibroscan
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: vibration controlled transient elastography (VCTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of fibrosis in patients with varying degrees of liver disease
single event per patient with liver disease to measure degree of fibrosis concentration
Measured: 10 years
Secondary outcomes (1)
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start28 Oct 2016
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease of Liver and Bile DuctStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Kaleida Health
- Responsible party
- Principal investigator, Ajay Chaudhuri, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897908
- Sponsor's protocol ID
- FibroScan
- Status last verified
- May 2026
- First submitted
- 3 Sep 2016
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
- ClinicalTrials.gov ID
- NCT02897908
- Acronym / sponsor ID
- FibroScan
- Conditions
- Disease of Liver and Bile Duct
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Kaleida Health
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver fibrosis and steatosis | – | Procedure: vibration controlled transient elastography (VCTE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibration controlled transient elastography (VCTE)Also: fibroscanOnce 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. | Procedure or surgery | liver fibrosis and steatosis |
Primary outcome
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
1 secondary outcome
measurement of liver fat in patients with varying degrees of liver disease
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease of Liver and Bile Duct, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajay Chaudhuri, MD (716-907-1916, achaudhu@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of fibrosis in patients with varying degrees of liver disease (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.