RecruitingNot ApplicableNCT06519331

Development of a New Method for Liver Stiffness Measurement Using FibroScan

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


Sponsor

Echosens

Enrollment

114 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

DEVICEResearch 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.


Locations(2)

Groupe Hospitalier Nord Essonne - Site Paris- Saclay

Orsay, France

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France

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NCT06519331


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