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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
389
Start Date
2025-11-14
Completion Date
2027-05-31
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
Research 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.
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