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NCT Number: NCT06519331

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pitié-Salpêtrière, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

    Correlation coefficients will be done.

  2. 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.

  3. 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.

  4. Bias between the CAP repetitions done with the Research FibroScan

    Time frame: 24 months

    Intra-class correlation coefficients will be done.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Llorca

CONTACT

[email protected]

+33144827850

Laura Cantu-Sanchez

CONTACT

[email protected]

+33144827850

Sponsors and collaborators

Lead sponsor

Echosens

Industry

Registry information

Official study title

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

Acronym: M148

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 25, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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