Development of a FibroScan Liver Examination Using a Single Probe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Research FibroScan.
- Who it may be relevant to
- Registry conditions: Liver Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
M149 - Development of a FibroScan Liver Examination Using a Single Probe
Overview
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).
Interventions
- Device 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
Primary outcome measures
- Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL). [Time frame: At Day 0]
Secondary outcome measures (4)
- Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes). [Time frame: At Day 0]
- Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL). [Time frame: At Day 0]
- Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL). [Time frame: At Day 0]
- To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+) [Time frame: At day 0]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Vulnerable patients.
- Patients with ascites.
- Patients with heart failure.
- Patients with acute hepatitis.
- Patients with biliary obstruction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- CHRU de Besançon — Besançon
- Hôpital St Eloi- CHU Montpellier — Montpellier
- Hôpital Paris Saclay — Orsay
Hong Kong · 1 center
- Prince of Wales Hospital the Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07400289 · M149