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Studies

Interventional Recruiting

NCT07400289 on ClinicalTrials.gov

Development of a FibroScan Liver Examination Using a Single Probe

Official title: M149 - Development of a FibroScan Liver Examination Using a Single Probe

  • Sponsor: Echosens
  • Collaborators: Novotech CRO
  • Enrollment: 389 (Estimated)
  • Study start: 2025-11-14 (Actual)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2027-05-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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).

Conditions

  • Liver Diseases

Intervention / Treatment

  • Device: Research FibroScan

Primary Outcome Measures

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

Countries

France, Hong Kong

Locations and Investigators

  • CHRU de Besançon, Besançon, France (Not yet recruiting)
    • Thierry Thevenot
    • Thierry Thevenot, Professor (Principal Investigator)
  • Hôpital St Eloi- CHU Montpellier, Montpellier, France (Not yet recruiting)
    • Stéphanie Faure, Medical doctor
    • Stéphanie Faure, Medical doctor (Principal Investigator)
  • Hôpital Paris Saclay, Orsay, France (Not yet recruiting)
    • Edoardo Poli, Medical doctor
    • Edoardo Poli, Medical doctor (Principal Investigator)
  • Prince of Wales Hospital the Chinese University of Hong Kong, Hong Kong, Hong Kong (Recruiting)
    • Vincent Wong, Professor
    • Vincent Wong (Principal Investigator)