Liver DiseasesM148NCT06519331
Development of a New Method for Liver Stiffness Measurement Using FibroScan
A study testing Research FibroScan (FS) in people with Liver Diseases, run by Echosens at 2 sites in France.
Trial summary
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan. 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
- 153 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Nov 2024to 1 Dec 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) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
- Adult patient able to give his written consent
- Patient affiliated to the French Social Security system
Who cannot join
- Vulnerable patients
- Patients with liver ascites
- Patients with heart failure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Groupe Hospitalier Nord Essonne - Site Paris- Saclay
Orsay, 91400
Edoardo Poli, Dr, +33 1 69 15 91 01, e.poli@gh-nord-essonne.fr
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
Vlad Ratziu, Pr, +33 1 42 17 76 22, vlad.ratziu@inserm.fr
About this study
Official title: M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.
- Conditions
- Liver Diseases
- Being tested
- Research FibroScan (FS)
- Keywords
- FibroScan, Vibration Controlled Transient Elastography, Liver Stiffness Measurement
- 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
Patients #1 to #25:
Exam 1: Examination with Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point and with the same probe used for the Exam 1.
Patients #26 to #75:
Exam 1: Examination with the Research or Reference FibroScan. Exam 2: Examination with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exam 1.
Patients #76 to #114:
Exams 1 \& 2: 2 consecutive examinations with the Research or Reference FibroScan.
Exams 3 \& 4: 2 consecutive examinations with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exams 1 \& 2.
| Study group | Role | What they receive |
|---|---|---|
| Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined | Experimental | Adult patients followed in the Hepatology or Endocrinology department for a liver disease, suspected chronic liver disease or consequences of chronic 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.
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.
Measured: 24 months
Secondary outcomes (4)
Bias between the different stiffness measurements (reference/estimated reference/at rest)
Correlation coefficients will be done.
Measured: 24 months
Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.
Intra-class correlation coefficients will be done.
Measured: 24 months
Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan
Correlation coefficients will be done.
Measured: 24 months
Bias between the CAP repetitions done with the Research FibroScan
Intra-class correlation coefficients will be done.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start8 Nov 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519331
- Sponsor's protocol ID
- M148
- Acronym
- M148
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2024
- 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
- M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan
- ClinicalTrials.gov ID
- NCT06519331
- Acronym / sponsor ID
- M148 / M148
- Conditions
- Liver Diseases
- Keywords
- FibroScan, Vibration Controlled Transient Elastography, Liver Stiffness Measurement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Jul 2024 (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 European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined | Experimental | Device: Research FibroScan (FS)Adult patients followed in the Hepatology or Endocrinology department for a liver disease, suspected chronic liver disease or consequences of 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 (3 listed)
- Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
- Adult patient able to give his written consent
- Patient affiliated to the French Social Security system
Key exclusion criteria (3 listed)
- Vulnerable patients
- Patients with liver ascites
- 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 |
|---|---|---|
| Research FibroScan (FS)Patients #1 to #25: Exam 1: Examination with Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #26 to #75: Exam 1: Examination with the Research or Reference FibroScan. Exam 2: Examination with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #76 to #114: Exams 1 \& 2: 2 consecutive examinations with the Research or Reference FibroScan. Exams 3 \& 4: 2 consecutive examinations with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exams 1 \& 2. | Device | Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined |
Primary outcome
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.
Time frame: 24 months
4 secondary outcomes
Bias between the different stiffness measurements (reference/estimated reference/at rest)
Time frame: 24 months
Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.
Time frame: 24 months
Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan
Time frame: 24 months
Bias between the CAP repetitions done with the Research FibroScan
Time frame: 24 months
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.
2 sites in 1 country: see every site and its status.
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 2 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 3 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 2 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?
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?
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method. (time frame: 24 months). 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.