Development of a New Method for Liver Stiffness Measurement Using FibroScan

N/ARecruitingNCT06519331

Echosens153 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

153

Conditions

Liver Diseases

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Groupe Hospitalier Nord Essonne - Site Paris- Saclay

Orsay, France

RECRUITING

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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

Correlation coefficients will be done.

Time frame: 24 months

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

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

Bias between the CAP repetitions done with the Research FibroScan

Intra-class correlation coefficients will be done.

Time frame: 24 months

Central Contacts

Anne Llorca

CONTACT

+33144827850 anne.llorca@echosens.com

Laura Cantu-Sanchez

CONTACT

+33144827850 laura.cantusanchez@echosens.com

Data from ClinicalTrials.gov

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