Development of a FibroScan Liver Examination Using a Single Probe

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• 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.

Trial sites (4)

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