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Development of a FibroScan Liver Examination Using a Single Probe

NCT07400289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2026-02-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Novotech CRO

    collaborator UNKNOWN

  • Echosens

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • France
  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400289 on ClinicalTrials.gov