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Recruiting NCT06519331

Development of a New Method for Liver Stiffness Measurement Using FibroScan

No phase Interventional Liver Diseases

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 (FS).
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
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

M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan

Overview

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

Interventions

  • Device Research FibroScan (FS)
    Patients #1 to #25: Exam 1: Examination with Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #26 to #75: Exam 1: Examination with the Research or Reference FibroScan. Exam 2: Examination with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #76 to #114: Exams 1 \& 2: 2 consecutive examinations with the Research or Ref

Primary outcome measures

  • Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method. [Time frame: 24 months]
Secondary outcome measures (4)
  • Bias between the different stiffness measurements (reference/estimated reference/at rest) [Time frame: 24 months]
  • Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions. [Time frame: 24 months]
  • Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan [Time frame: 24 months]
  • Bias between the CAP repetitions done with the Research FibroScan [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
  • Adult patient able to give his written consent
  • Patient affiliated to the French Social Security system

Exclusion criteria

  • Vulnerable patients
  • Patients with liver ascites
  • Patients with heart failure

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 · 2 centers
  • Groupe Hospitalier Nord Essonne - Site Paris- Saclay — Orsay
  • Hôpital Pitié-Salpêtrière — Paris

Identifiers

NCT: NCT06519331 · M148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗