NCT07400289

Development of a FibroScan Liver Examination Using a Single Probe

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (estimated)
• Sponsor: Echosens · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Liver Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

4 sites across 2 countries: France, Hong Kong