Non-Alcoholic Fatty Liver DiseaseFibroScan-RRNCT06877026
FibroScan-Reproducibility and Repeatability Study
A study testing FibroScan and Liver Enzymes in people with Non-Alcoholic Fatty Liver Disease and Liver Disease; Alcohol-Related, run by Echosens at 1 site in United Kingdom.
Trial summary
Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. Early detection is crucial to help prevent these outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Liver Disease; Alcohol-Related
- What is being tested?
- FibroScan and Liver Enzymes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult patients (age ≥ 18 y.o) with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD), Metabolic and Alcohol-related Liver Disease (MetALD), and Alcohol-related Liver Disease (ALD).
- Adult patients able to give written informed consent.
Who cannot join
- Vulnerable patients
- Patients with other chronic liver disease including but not limited to hepatitis B, hepatitis C, autoimmune hepatitis, cholestatic diseases
- Patients with ascites
- Patients with elevated conjugated bilirubin (>1.5 ULN)
- Patients with heart failure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
About this study
Official title: Evaluating the Repeatability and Reproducibility of FibroScan Generations
Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. Early detection is crucial to help prevent these outcomes. Liver stiffness measurement (LSM) can detect fibrosis (scarring) in the liver, a common issue in CLD patients while traditional methods like liver biopsy are invasive and not ideal for regular screening and monitoring.
FibroScan, a non-invasive device, measures the liver stiffness and fat content in the liver. This study will assess how reliable and consistent FibroScan results are when used by different operators and across different days, focusing on patients with liver conditions like metabolic-related liver disease (MASLD), alcohol-related liver disease (ALD), and hepatitis B. This research also aims to test both the standard and Guided VCTE (Vibration Controlled Transient Elastography) FibroScan generations to evaluate their reproducibility and repeatability. As secondary objectives the Control Attenuation Parameter (CAP) results, and the FAST, Agile 3+, and Agile 4 scores will be evaluated to compare their reproducibility and repeatability.
Read more
Adult participants will attend two visits within three days. During these visits, they will undergo multiple FibroScan scans that include five scans on Day 1 (visit 1) and four scans on the follow up visit (visit 2), one blood sample for liver health assessment on each visit, and an AUDIT questionnaire on Day 1 (visit 1). Some participants may undergo only two scans on the follow-up visit since this will depend on operator availability. Each session will last 25-45 minutes including all examination types.
The study is funded by Echosens, the manufacturer of FibroScan, and will be conducted at UK healthcare facilities in England. By evaluating the variability of FibroScan results, this research could lead to a better understanding of the device's reproducibility and reliability in measuring liver stiffness across different operators and time points, potentially enhancing clinical confidence in its use for managing chronic liver diseases.
- Being tested
- FibroScan, Liver Enzymes
- Keywords
- FibroScan, Reproducibility, Repeatability
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDevice
Day 1 = 5 FibroScan examinations Day 2 = 4 FibroScan examinations
Liver EnzymesOther
Day = 1 blood collection for liver enzymes. Day 2= 1 blood collection for liver enzymes.
| Study group | Role | What they receive |
|---|---|---|
| Full Cohort | Experimental | This population will be defined by patients fulfilling all inclusion and exclusion criteria. Receives: Device: FibroScan; Other: Liver Enzymes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if guided VCTE, as opposed to a standard examination, improves LSM reproducibility across different days and different operators.
Reproducibility of LSM by Guided VCTE versus standard examination, when performed on different days and by different operators. Day 1 is the first visit and Day X is the follow up visit. Day X can be up to 3 days after the Day 1 visit.
Measured: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit).
Secondary outcomes (4)
To determine if guided VCTE, as opposed to a standard examination, improves CAP, FAST, Agile 3+ and Agile 4 reproducibility across different days and different operators.
Reproducibility of CAP, FAST, Agile 3+ and Agile 4 by Guided VCTE versus standard examination, when performed on different days (Day 1 and Day X, X≤ 3 calendar days after Day 1) and by different operators
Measured: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit)
To determine if guided VCTE, as opposed to a standard examination, improves LSM and CAP, FAST, Agile 3+ and Agile 4 reproducibility across different days with the same operator.
Reproducibility of LSM and CAP, FAST, Agile 3+ and Agile 4 by Guided VCTE versus standard examination, when performed on different days (Day 1 and Day X, X≤ 3 calendar days after Day 1) by the same operator
Measured: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit)
To determine if guided VCTE, as opposed to a standard examination, improves LSM and CAP, FAST, Agile 3+ and Agile 4 repeatability on the same day with the same operator
Repeatability of LSM and CAP, FAST, Agile 3+ and Agile 4 by Guided VCTE versus standard examination, when performed on the same day (Day 1 only) and by the same operator
Measured: Day 1 only (1st visit only)
To evaluate the effect of resting time vs no resting time before the FibroScan Standard examination for both LSM and CAP.
Repeatability of LSM and CAP, FAST, Agile 3+ and Agile 4 by Guided VCTE with (5 minutes) or without resting time and with or without control breathing performed on the same day (Day 1 only) by the same operator
Measured: Day 1 only (1st visit only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start16 Jul 2025
- Primary completion25 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877026
- Sponsor's protocol ID
- M141
- Acronym
- FibroScan-RR
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Repeatability and Reproducibility of FibroScan Generations
- ClinicalTrials.gov ID
- NCT06877026
- Acronym / sponsor ID
- FibroScan-RR / M141
- Keywords
- FibroScan, Reproducibility, Repeatability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- 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.
Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. Early detection is crucial to help prevent these outcomes. Liver stiffness measurement (LSM) can detect fibrosis (scarring) in the liver, a common issue in CLD patients while traditional methods like liver biopsy are invasive and not ideal for regular screening and monitoring.
FibroScan, a non-invasive device, measures the liver stiffness and fat content in the liver. This study will assess how reliable and consistent FibroScan results are when used by different operators and across different days, focusing on patients with liver conditions like metabolic-related liver disease (MASLD), alcohol-related liver disease (ALD), and hepatitis B. This research also aims to test both the standard and Guided VCTE (Vibration Controlled Transient Elastography) FibroScan generations to evaluate their reproducibility and repeatability. As secondary objectives the Control Attenuation Parameter (CAP) results, and the FAST, Agile 3+, and Agile 4 scores will be evaluated to compare their reproducibility and repeatability.
Adult participants will attend two visits within three days. During these visits, they will undergo multiple FibroScan scans that include five scans on Day 1 (visit 1) and four scans on the follow up visit (visit 2), one blood sample for liver health assessment on each visit, and an AUDIT questionnaire on Day 1 (visit 1). Some participants may undergo only two scans on the follow-up visit since this will depend on operator availability. Each session will last 25-45 minutes including all examination types.
The study is funded by Echosens, the manufacturer of FibroScan, and will be conducted at UK healthcare facilities in England. By evaluating the variability of FibroScan results, this research could lead to a better understanding of the device's reproducibility and reliability in measuring liver stiffness across different operators and time points, potentially enhancing clinical confidence in its use for managing chronic liver diseases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Cohort | Experimental | Device: FibroScan, Other: Liver EnzymesThis population will be defined by patients fulfilling all inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 y.o) with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD), Metabolic and Alcohol-related Liver Disease (MetALD), and Alcohol-related Liver Disease (ALD).
- Adult patients able to give written informed consent.
Key exclusion criteria (5 listed)
- Vulnerable patients
- Patients with other chronic liver disease including but not limited to hepatitis B, hepatitis C, autoimmune hepatitis, cholestatic diseases
- Patients with ascites
- Patients with elevated conjugated bilirubin (>1.5 ULN)
- Patients with heart failure
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 |
|---|---|---|
| FibroScanDay 1 = 5 FibroScan examinations Day 2 = 4 FibroScan examinations | Device | Full Cohort |
| Liver EnzymesDay = 1 blood collection for liver enzymes. Day 2= 1 blood collection for liver enzymes. | Other | Full Cohort |
Primary outcome
To determine if guided VCTE, as opposed to a standard examination, improves LSM reproducibility across different days and different operators.
Time frame: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit).
Reproducibility of LSM by Guided VCTE versus standard examination, when performed on different days and by different operators. Day 1 is the first visit and Day X is the follow up visit. Day X can be up to 3 days after the Day 1 visit.
4 secondary outcomes
To determine if guided VCTE, as opposed to a standard examination, improves CAP, FAST, Agile 3+ and Agile 4 reproducibility across different days and different operators.
Time frame: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit)
To determine if guided VCTE, as opposed to a standard examination, improves LSM and CAP, FAST, Agile 3+ and Agile 4 reproducibility across different days with the same operator.
Time frame: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit)
To determine if guided VCTE, as opposed to a standard examination, improves LSM and CAP, FAST, Agile 3+ and Agile 4 repeatability on the same day with the same operator
Time frame: Day 1 only (1st visit only)
To evaluate the effect of resting time vs no resting time before the FibroScan Standard examination for both LSM and CAP.
Time frame: Day 1 only (1st visit only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan and Liver Enzymes in people with Non-Alcoholic Fatty Liver Disease and Liver Disease; Alcohol-Related, run by Echosens at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 13 Apr 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if guided VCTE, as opposed to a standard examination, improves LSM reproducibility across different days and different operators. (time frame: From Day 1 (first visit) to Day X (follow up visit, Day X can be up to 3 days after Day 1visit).). 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 13 Apr 2026.