Development of a New Method for Liver Stiffness Measurement Using FibroScan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2027-05-31

Brief Summary

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This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

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Detailed Description

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Conditions

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Liver Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined

Adult patients followed in the Hepatology or Endocrinology department for a liver disease, suspected chronic liver disease or consequences of chronic liver disease, all etiologies combined.

Group Type EXPERIMENTAL

Research FibroScan (FS)

Intervention Type 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.

Interventions

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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 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.

Intervention Type DEVICE

Eligibility Criteria

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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