New method to measure liver stiffness with FibroScan
M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan
NA · Echosens · NCT06519331
This project will test a new way to measure liver stiffness with a FibroScan device in adults being treated for or suspected of having liver disease at two French hospitals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Echosens (industry) |
| Locations | 2 sites (Orsay and 1 other locations) |
| Trial ID | NCT06519331 on ClinicalTrials.gov |
What this trial studies
This is a prospective, interventional, multicenter investigation at two French sites enrolling 114 adults to develop a new liver stiffness measurement method using a Research FibroScan device. Participants followed in hepatology or endocrinology clinics who can give written consent and are affiliated with the French social security system will undergo FibroScan examinations and related data collection. Vulnerable patients and those with ascites or heart failure are excluded. Collected measurements will be used to refine and validate the new measurement approach.
Who should consider this trial
Good fit: Adults (≥18) followed for or suspected of having liver disease in hepatology or endocrinology clinics who can give written consent and are affiliated with the French social security system.
Not a fit: Vulnerable patients and those with liver ascites or heart failure are excluded and thus will not participate or benefit, and participants may not receive direct clinical benefit because the focus is on method development.
Why it matters
Potential benefit: If successful, the method could provide clinicians a more accurate or reliable noninvasive measure of liver stiffness, aiding diagnosis and monitoring.
How similar studies have performed: Vibration-controlled transient elastography (FibroScan) is an established, widely studied technique for noninvasive liver stiffness measurement, though this particular new measurement method is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Vulnerable patients * Patients with liver ascites * Patients with heart failure
Where this trial is running
Orsay and 1 other locations
- Groupe Hospitalier Nord Essonne - Site Paris- Saclay — Orsay, France (RECRUITING)
- Hôpital Pitié-Salpêtrière — Paris, Île-de-France Region, France (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.
Conditions: Liver Diseases, FibroScan, Vibration Controlled Transient Elastography, Liver Stiffness Measurement