Liver DiseasesM149NCT07400289
Development of a FibroScan Liver Examination Using a Single Probe
A study testing Research FibroScan in people with Liver Diseases, run by Echosens at 4 sites in 2 countries.
Trial summary
This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Nov 2025to 31 May 2027
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients (≥ 18 years of age).
- Patient followed with a chronic liver disease.
- Adult patient able to give his written consent.
- For European sites: patient affiliated to the healthcare system.
Who cannot join
- Vulnerable patients.
- Patients with ascites.
- Patients with heart failure.
- Patients with acute hepatitis.
- Patients with biliary obstruction.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
France3 sites, 3 recruiting
- Not yet recruiting
CHRU de Besançon
Besançon, 25000
Thierry Thevenot, +333 81 66 84 21, tthevenot@chu-besancon.fr
Thierry Thevenot, Professor
- Not yet recruiting
Hôpital St Eloi- CHU Montpellier
Montpellier, 34090
Stéphanie Faure, Medical doctor, +334 67 33 75 45, s-faure@chu-montpellier.fr
Stéphanie Faure, Medical doctor
- Not yet recruiting
Hôpital Paris Saclay
Orsay, 91400
Edoardo Poli, Medical doctor, +331 69 15 93 74, E.POLI@gh-nord-essonne.fr
Edoardo Poli, Medical doctor
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital the Chinese University of Hong Kong
Hong Kong
Vincent Wong, Professor, +852 3505-1299, wongv@cuhk.edu.hk
Vincent Wong
About this study
Official title: M149 - Development of a FibroScan Liver Examination Using a Single Probe
This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).
- Conditions
- Liver Diseases
- Being tested
- Research FibroScan
- Keywords
- FibroScan, Liver stiffness Measurement, Vibration Controlled Transient Elastography
- 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 FibroScanDevice
Patients #001-050: three exploratory examinations using three different Single Probes (SP#1, SP#2 and SP#3), followed by one standard FibroScan examination (M+/XL+). An interim analysis will determine the SP to be used thereafter.
Patients #051-090 (BMI ≥35 kg/m²): one SP examination and one standard examination.
Patients #091-349: one SP examination, one standard examination with the recommended reference probe, and one additional standard examination with the non-recommended probe.
Patients #350-389: two SP examinations and two standard examinations to assess repeatability.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Adult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined. Receives: Device: Research FibroScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL).
This outcome assesses the difference between the values of LSM obtained with the single probe and the reference probes (M and XL) when performed in the same patients.
Measured: At Day 0
Secondary outcomes (4)
Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes).
This outcome compare the applicability of FibroScan examinations performed with the single probe compared with the reference probes (M and XL).
Measured: At Day 0
Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL).
This outcome assesses the difference between the CAP measurements obtained with the single probe and the reference probes (M and XL) when performed in the same patients.
Measured: At Day 0
Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL).
This outcome evaluates the difference in patient-reported comfort following FibroScan examinations performed with the single probe versus the reference probes (M and XL), as reported by patients after undergoing the examinations under similar conditions. A comfort scale from 0 to 10 will be given to the patients, where 10 represents the most confortable and 0 the more incomfortable.
Measured: At Day 0
To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+)
Repeatability of liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) will be evaluated from duplicate measurements performed with the Single Probe (SP) and duplicate measurements performed with the recommended reference probe (M+ or XL+) during the same study visit. The consistency between repeated measurements for each probe type will be assessed.
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start14 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- 389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400289
- Sponsor's protocol ID
- M149
- Acronym
- M149
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M149 - Development of a FibroScan Liver Examination Using a Single Probe
- ClinicalTrials.gov ID
- NCT07400289
- Acronym / sponsor ID
- M149 / M149
- Conditions
- Liver Diseases
- Keywords
- FibroScan, Liver stiffness Measurement, Vibration Controlled Transient Elastography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 389 participants (estimated)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Collaborators
- Novotech CRO
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Feb 2026 (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.
This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Research FibroScanAdult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years of age).
- Patient followed with a chronic liver disease.
- Adult patient able to give his written consent.
- For European sites: patient affiliated to the healthcare system.
Key exclusion criteria (5 listed)
- Vulnerable patients.
- Patients with ascites.
- Patients with heart failure.
- Patients with acute hepatitis.
- Patients with biliary obstruction.
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 |
|---|---|---|
| Research FibroScanPatients #001-050: three exploratory examinations using three different Single Probes (SP#1, SP#2 and SP#3), followed by one standard FibroScan examination (M+/XL+). An interim analysis will determine the SP to be used thereafter. Patients #051-090 (BMI ≥35 kg/m²): one SP examination and one standard examination. Patients #091-349: one SP examination, one standard examination with the recommended reference probe, and one additional standard examination with the non-recommended probe. Patients #350-389: two SP examinations and two standard examinations to assess repeatability. | Device | All patients |
Primary outcome
Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL).
Time frame: At Day 0
This outcome assesses the difference between the values of LSM obtained with the single probe and the reference probes (M and XL) when performed in the same patients.
4 secondary outcomes
Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes).
Time frame: At Day 0
Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL).
Time frame: At Day 0
Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL).
Time frame: At Day 0
To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+)
Time frame: At day 0
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 5 Aug 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research FibroScan in people with Liver Diseases, run by Echosens at 4 sites in 2 countries.
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 4 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Hong Kong. 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 Anne Llorca (+33144827850, anne.llorca@echosens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL). (time frame: At Day 0). 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 5 Aug 2026.