NCT07400289

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2025

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Nov 2025May 2027

Study Start

First participant enrolled

November 14, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

December 22, 2025

Last Update Submit

August 3, 2026

Conditions

Liver Diseases

Keywords

FibroScanLiver stiffness MeasurementVibration Controlled Transient Elastography

Outcome Measures

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).

    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.

    At Day 0

Secondary Outcomes (4)

  • 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).

    At Day 0

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

    At Day 0

  • 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).

    At Day 0

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

    At day 0

Study Arms (1)

All patients

EXPERIMENTAL

Adult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined.

Device: Research FibroScan

Interventions

Research FibroScanDEVICE

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.

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU de Besançon

Besançon, 25000, France

NOT YET RECRUITING

Hôpital St Eloi- CHU Montpellier

Montpellier, 34090, France

NOT YET RECRUITING

Hôpital Paris Saclay

Orsay, 91400, France

NOT YET RECRUITING

Prince of Wales Hospital the Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Anne Llorca

CONTACT

+33144827850anne.llorca@echosens.com

Laura Cantu Sanchez

CONTACT

+33144827850laura.cantusanchez@echosens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

February 10, 2026

Study Start

November 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations

HK(1)FR(3)