Health TrialsbyHealthPanel

Development of a New Method for Liver Stiffness Measurement Using FibroScan

ConditionLiver Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEchosens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Vulnerable patients

Patients with liver ascites

Patients with heart failure

Trial design

Design model

Single group

Treatments tested in this trial

  • Research FibroScan (FS)

    Device

    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 Reference FibroScan. Exams 3 \& 4: 2 consecutive examinations with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exams 1 \& 2.

Treatment groups

153 Participants
are divided into 1 treatment group
Group A: Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combinedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.

Time frame
24 months

Secondary outcomes

1

Bias between the different stiffness measurements (reference/estimated reference/at rest)

Correlation coefficients will be done.

Time frame
24 months
2

Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.

Intra-class correlation coefficients will be done.

Time frame
24 months
3

Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan

Correlation coefficients will be done.

Time frame
24 months
4

Bias between the CAP repetitions done with the Research FibroScan

Intra-class correlation coefficients will be done.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Echosens

Lead sponsor

Source ClinicalTrials.gov
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