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RECRUITING
NCT07400289
NA

Development of a FibroScan Liver Examination Using a Single Probe

Sponsor: Echosens

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

309

Start Date

2025-11-14

Completion Date

2026-12-31

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Research FibroScan

\*Patients #1 to #50: Exam 1: Examination with Research FibroScan and single probe #1 (SP1). Exam 2: Examination with Research FibroScan and single probe #2 (SP2). Exam 3: Examination with Research FibroScan and single probe #3 (SP3). Exam 4: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the FS exam using the SP1 probe, the SP2 probe or the SP3 probe to avoid potential bias. The standard examination must be always done at the end, after the first 3 exploratory exams. \*Patients #51 to #309: Exam 1: Examination with the Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the Research FibroScan and the Reference FibroScan to avoid potential bias.

Locations (4)

CHRU de Besançon

Besançon, France

Hôpital St Eloi- CHU Montpellier

Montpellier, France

Hôpital Paris Saclay

Orsay, France

Prince of Wales Hospital the Chinese University of Hong Kong

Hong Kong, Hong Kong