Single-probe FibroScan for measuring liver stiffness
M149 - Development of a FibroScan Liver Examination Using a Single Probe
This project will try a single-probe FibroScan to measure liver stiffness in adults with chronic liver disease and compare its results to the standard M and XL probes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 309 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Echosens Industry-sponsored |
| Locations | 4 sites (Besançon and 3 other locations) |
| Trial ID | NCT07400289 on ClinicalTrials.gov |
What this trial studies
This is an international, prospective, multicenter interventional investigation enrolling about 309 adults at one Hong Kong site and three French sites to compare liver stiffness measurements (LSM) obtained with a new single probe versus the reference M and XL FibroScan probes. Participants with chronic liver disease will undergo FibroScan examinations using both the single probe and the reference probes to test reproducibility of LSM. Key exclusions include ascites, heart failure, acute hepatitis, biliary obstruction, and vulnerable patients. The primary objective is to quantify agreement and variability between the single-probe and reference-probe measurements across a broad clinical population.
Who should consider this trial
Good fit: Adults (≥18 years) being followed for chronic liver disease who can give written informed consent (European participants must be affiliated with the healthcare system) are the intended candidates.
Not a fit: Patients with ascites, heart failure, acute hepatitis, biliary obstruction, or those classified as vulnerable are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, a validated single probe could simplify and standardize FibroScan exams, making liver stiffness testing easier and more consistent for patients and clinics.
How similar studies have performed: Standard FibroScan using M and XL probes is well established, but using a single probe is a newer approach with limited prior validation data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Besançon and 3 other locations
- CHRU de Besançon — Besançon, France (Not_yet_recruiting)
- Hôpital St Eloi- CHU Montpellier — Montpellier, France (Not_yet_recruiting)
- Hôpital Paris Saclay — Orsay, France (Not_yet_recruiting)
- Prince of Wales Hospital the Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Anne Llorca
- Email: anne.llorca@echosens.com
- Phone: +33144827850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.