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Development of a FibroScan Liver Examination Using a Single Probe
Sponsor: Echosens
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).
Official title: M149 - Development of a FibroScan Liver Examination Using a Single Probe
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
309
Start Date
2025-11-14
Completion Date
2026-12-31
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
CHRU de Besançon
Besançon, France
Hôpital St Eloi- CHU Montpellier
Montpellier, France
Hôpital Paris Saclay
Orsay, France
Prince of Wales Hospital the Chinese University of Hong Kong
Hong Kong, Hong Kong