RecruitingNot ApplicableNCT07400289

Development of a FibroScan Liver Examination Using a Single Probe

M149 - Development of a FibroScan Liver Examination Using a Single Probe

Sponsor

Echosens

Enrollment

309 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Liver Diseases

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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

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Interventions

DEVICEResearch 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.