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

August 11, 2025 updated by: Echosens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Orsay, France, 91400
        • Recruiting
        • Groupe Hospitalier Nord Essonne - Site Paris- Saclay
        • Contact:
    • Ile de France
      • Paris, Ile de France, France, 75013
        • Recruiting
        • Hôpital Pitié-Salpétrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bias between the different stiffness measurements (reference/estimated reference/at rest)
Time Frame: 24 months
Correlation coefficients will be done.
24 months
Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.
Time Frame: 24 months
Intra-class correlation coefficients will be done.
24 months
Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan
Time Frame: 24 months
Correlation coefficients will be done.
24 months
Bias between the CAP repetitions done with the Research FibroScan
Time Frame: 24 months
Intra-class correlation coefficients will be done.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Echosens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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