Liver Diseases
Conditions
Keywords
FibroScan, Liver stiffness Measurement, Vibration Controlled Transient Elastography
Brief 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. 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).
Interventions
DEVICEResearch FibroScan
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.
Sponsors
Echosens
Novotech CRO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | At Day 0 | This outcome compare the applicability of FibroScan examinations performed with the single probe compared with the reference probes (M and XL). |
| Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL). | 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. |
| 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). | 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. |
| To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+) | At day 0 | 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. |
Countries
France, Hong Kong
Contacts
CONTACTAnne Llorca
CONTACTLaura Cantu Sanchez
Outcome results
None listed