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

Echosens North America

Status: Not yet enrolling

Conditions: Liver Diseases

Treatments: Device: Research FibroScan (FS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06519331

M148

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Research FibroScan (FS)