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NCT Number: NCT07400289

Development of a FibroScan Liver Examination Using a Single Probe

This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).

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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

CHRU de Besançon, Besançon, 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).
  • Patient followed with a chronic liver disease.
  • Adult patient able to give his written consent.
  • For European sites: patient affiliated to the healthcare system.

Exclusion criteria

  • Vulnerable patients.
  • Patients with ascites.
  • Patients with heart failure.
  • Patients with acute hepatitis.
  • Patients with biliary obstruction.

Treatment and study plan

Research FibroScan

Device

Patients #001-050: three exploratory examinations using three different Single Probes (SP#1, SP#2 and SP#3), followed by one standard FibroScan examination (M+/XL+). An interim analysis will determine the SP to be used thereafter.

Patients #051-090 (BMI ≥35 kg/m²): one SP examination and one standard examination.

Patients #091-349: one SP examination, one standard examination with the recommended reference probe, and one additional standard examination with the non-recommended probe.

Patients #350-389: two SP examinations and two standard examinations to assess repeatability.

Primary outcomes

  1. Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL).

    Time frame: At Day 0

    This outcome assesses the difference between the values of LSM obtained with the single probe and the reference probes (M and XL) when performed in the same patients.

Secondary outcomes

  1. Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes).

    Time frame: At Day 0

    This outcome compare the applicability of FibroScan examinations performed with the single probe compared with the reference probes (M and XL).

  2. Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL).

    Time frame: At Day 0

    This outcome assesses the difference between the CAP measurements obtained with the single probe and the reference probes (M and XL) when performed in the same patients.

  3. Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL).

    Time frame: At Day 0

    This outcome evaluates the difference in patient-reported comfort following FibroScan examinations performed with the single probe versus the reference probes (M and XL), as reported by patients after undergoing the examinations under similar conditions. A comfort scale from 0 to 10 will be given to the patients, where 10 represents the most confortable and 0 the more incomfortable.

  4. To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+)

    Time frame: At day 0

    Repeatability of liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) will be evaluated from duplicate measurements performed with the Single Probe (SP) and duplicate measurements performed with the recommended reference probe (M+ or XL+) during the same study visit. The consistency between repeated measurements for each probe type will be assessed.

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

Collaborators

  • Novotech CRO

Registry information

Official study title

M149 - Development of a FibroScan Liver Examination Using a Single Probe

Acronym: M149

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Aug 5, 2026

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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