Development of a FibroScan Liver Examination Using a Single Probe (M149)

February 3, 2026 updated by: Echosens

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

309

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25000
        • Not yet recruiting
        • CHRU De Besancon
        • Contact:
        • Principal Investigator:
          • Thierry Thevenot, Professor
      • Montpellier, France, 34090
        • Not yet recruiting
        • Hôpital St Eloi- CHU Montpellier
        • Contact:
        • Principal Investigator:
          • Stéphanie Faure, Medical doctor
      • Orsay, France, 91400
        • Not yet recruiting
        • Hôpital Paris Saclay
        • Contact:
        • Principal Investigator:
          • Edoardo Poli, Medical doctor
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital the Chinese University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Vincent Wong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Vulnerable patients.
  • Patients with ascites.
  • Patients with heart failure.
  • Patients with acute hepatitis.
  • Patients with biliary obstruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
Adult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined.
Device: Research FibroScan

*Patients #1 to #50: Exam 1: Examination with Research FibroScan and single probe #1 (SP1). Exam 2: Examination with Research FibroScan and single probe #2 (SP2). Exam 3: Examination with Research FibroScan and single probe #3 (SP3). Exam 4: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the FS exam using the SP1 probe, the SP2 probe or the SP3 probe to avoid potential bias.

The standard examination must be always done at the end, after the first 3 exploratory exams.

*Patients #51 to #309: Exam 1: Examination with the Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the Research FibroScan and the Reference FibroScan to avoid potential bias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL).
Time Frame: At Day 0
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.
At Day 0
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
This outcome compare the applicability of FibroScan examinations performed with the single probe compared with the reference probes (M and XL).
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
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.
At Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Echosens

Collaborators

Novotech CRO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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