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Liver DiseasesNCT05567328

Validation of the New Vibration-guided FibroScan Examination

A study testing Research FibroScan (FS) in people with Liver Diseases, run by Echosens at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Diseases
What is being tested?
Research FibroScan (FS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
3 sitesFrance
Study dates
26 Oct 2022to 20 Dec 2024
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 years old) followed for a liver disease; a suspicion of liver disease or for consequences of liver disease, all etiologies combined
  • Patient must be able to give written informed consent
  • Patient affiliated to a social security system

Who cannot join

  • Vulnerable patient
  • Patients with ascites

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Hôpital Beaujon

    Clichy, 92110

  • Hospices Civils de Lyon - Lyon Sud

    Lyon, 69495

  • CHU de Nancy

    Nancy

Other trials in France

About this study

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

Read the detailed description

Chronic liver disease (CLD) is a silent disease that can progress to life-threatening conditions. Hepatitis B (HBV) and C (HCV) viruses, alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD) are the main causes of chronic liver inflammation.

CLDs represent a major public health burden, with global estimates showing around a rate of 2 million deaths per year, including 1 million from complications of cirrhosis and 1 million from viral hepatitis and hepatocellular carcinoma. About 75 million people are diagnosed with alcohol use disorders and are at risk of developing alcohol-related liver disease. About 2 billion adults are obese or overweight and more than 400 million suffer from diabetes; both of which are risk factors for the development of NAFLD and HCC.

NAFLD is currently the leading cause of CLD worldwide with a reported worldwide prevalence of 25% in adults. Early identification among NAFLD patients with non-alcoholic steatohepatatis (NASH) and advanced fibrosis is particularly important as they are at high risk of developing liver complications. The main difficulty in diagnosing NASH patients is related to their symptomatology, which is not always clinically useful because it is not specific. Therefore a screening for advanced stage of NAFLD is recommended in patient at high risk such patients with type 2 diabetes or obesity.

Liver fibrosis is known to be a major prognostic predictor of hepatic and overall mortality in patients with CLD. Therefore, early diagnosis of liver fibrosis is crucial in asymptomatic individuals.

Liver biopsy (LB) is the gold standard diagnostic test for the evaluation of patients with CLD. However, it is difficult to use it as a screening tool given the large number of patients with NAFLD.

The development of non-invasive and broadly applicable screening tools for the assessment of liver fibrosis appears to be a major public health opportunity.

Among the non-invasive tools available, the FibroScan (Echosens™, Paris, France) has proven to be a useful tool for diagnosing fibrosis and steatosis in patients with CLD. FibroScan is a device based on Vibration-Controlled Transient Elastography (VCTE™) technology that measures Liver Stiffness Elasticity (LSM) to assess fibrosis and Controlled Attenuation Parameter (CAP) to assess steatosis.

In this context, Echosens aims to develop a new technology called "Vibration-Guided Transient Elastography (VGTE)" which is an original method that will help FibroScan operators to localize an optimal region of interest for stiffness measurement in a simple and reliable way.

Conditions
Liver Diseases
Being tested
Research FibroScan (FS)
Keywords
FibroScan, Vibration Control Transient Elastography, Vibration Guided Transient Elastography, Liver Stiffness Measurement, VCTE, VGTE
Medical subject headings
Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Research FibroScan (FS)Device

    Exams will be performed with the M or XL probe as per FS recommendations. Same probe must be used for all exams Exploratory exam after patient 151 are performed with adapted view of Research FS

    Patients 1 to 90 \& 151 to 190 Exam1 Exploratory exam with the Research FS Exam2 Reference exam with the CE-marked FS

    Patients 91 to 130 \& 191 to 230 Exams1\&2 Two consecutive Exploratory exams with the Research FS Exams3\&4 Two consecutive Reference exams with the CE-marked FS

    Patients 131 to 150 Exams1\&2 Two consecutive Exploratory exams with automatic function of the Research FS Exam3 Reference exam with the CE-marked FS

    Patients 231 to 270 Exams1 (novice operator) Exploratory exam with the Research FS Exams2 (novice operator) Reference exam with the CE-marked FS Exams3 (experienced/expert operator) Exploratory exam with the Research FS Exams4 (experienced/expert operator) Reference exam with the CE-marked FS

Study groups in NCT05567328
Study groupRoleWhat they receive
Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combinedExperimentalAdult patients followed in the Hepatology or Endocrinology department for a liver disease, all etiologies combined.
Receives: Device: Research FibroScan (FS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination

    To compare the applicability between the novel FibroScan and the reference FibroScan examination performed on the liver

    Measured: 17 months

Secondary outcomes (9)

  1. Difference of success rate between the novel and the reference FibroScan examination

    To compare the success rate between the novel and the reference FibroScan examination

    Measured: 17 months

  2. Difference between the initial localization durations required for the novel and the reference FibroScan examination.

    To compare, between the novel and the reference examination, the duration of the initial localization, defined between the time the operator places the probe on the patient and the time needed to obtain the first valid stiffness measurement

    Measured: 17 months

  3. Difference between the examination durations required for the novel and the reference examination based on liver stiffness measurements.

    To compare between the novel and the reference examination the duration between the time of the operator places the probe on the patient and the time he obtains 10 valid liver stiffness measurements

    Measured: 17 months

  4. Difference between the examination durations required for the novel and the reference examination based on CAP measurements.

    To compare between the novel and the reference examination, the duration between the time of the operator places the probe on the patient and the time he obtains the CAP value with the gauge at 100%.

    Measured: 17 months

  5. Intraclass Correlation Coefficient (ICC) between novel and reference FibroScan examinations

    To compare the agreement of CAP, stiffness and skin to capsule distance (SCD) between the novel and the reference examination

    Measured: 17 months

  6. Evaluation of the operator perception between the novel and reference examination

    To compare with a dedicated questionnaire (quantitative scale), the operator perception related to the probe vibration, indicator display and easy of use.

    Measured: 17 months

  7. Evaluation of the patient perception between the novel and reference examination

    To compare with a dedicated questionnaire (quantitative scale), the patient perception related to the probe vibration

    Measured: 17 months

  8. ICC between the two novel FibroScan examinations and the two reference FibroScan examinations and coefficient of repeatability of stiffness and CAP examination performed by the same operator, on the same patient the same day.

    To evaluate the repeatability (same day, same operator) of the stiffness and the CAP measurements of the novel and the reference examinations

    Measured: 17 months

  9. ICC between novel and reference FibroScan examinations based on the operator's level expertise and coefficient of reproducibility of stiffness and CAP examination performed by the 2 different operators, on the same patient the same day.

    To evaluate the inter-operator reproducibility of the stiffness and the CAP measurements of the novel and the reference examination, based on the operator's level of expertise.

    Measured: 17 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start26 Oct 2022
  3. Primary completion20 Dec 2024
  4. Study completion20 Dec 2024

Resources

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
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567328
Sponsor's protocol ID
M140
Status last verified
Jan 2025
First submitted
26 Sep 2022
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bastard C, Audiere S, Foucquier J, Loree H, Miette V, Bronowicki JP, Stern C, Caussy C, Sandrin L. Guided-VCTE: An Enhanced FibroScan Examination With Improved Guidance and Applicability. Ultrasound Med Biol. 2025 Apr;51(4):628-637. doi: 10.1016/j.ultrasmedbio.2024.12.007. Epub 2025 Jan 13.

    PubMed 39809636

Questions about this trial

What is this clinical trial studying?

A study testing Research FibroScan (FS) in people with Liver Diseases, run by Echosens at 3 sites in France.

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 2 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination (time frame: 17 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567328, which also lists 1 linked publication.

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 15 Jan 2025.

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