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Validation of the New Vibration-guided FibroScan Examination

NCT05567328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-01-15

No results posted yet for this study

Summary

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

Conditions

Interventions

DEVICE

Research FibroScan (FS)

Exams will be performed with the M or XL probe as per FS recommendations. Same probe must be used for all exams Exploratory exam after patient 151 are performed with adapted view of Research FS Patients 1 to 90 \& 151 to 190 Exam1 Exploratory exam with the Research FS Exam2 Reference exam with the CE-marked FS Patients 91 to 130 \& 191 to 230 Exams1\&2 Two consecutive Exploratory exams with the Research FS Exams3\&4 Two consecutive Reference exams with the CE-marked FS Patients 131 to 150 Exams1\&2 Two consecutive Exploratory exams with automatic function of the Research FS Exam3 Reference exam with the CE-marked FS Patients 231 to 270 Exams1 (novice operator) Exploratory exam with the Research FS Exams2 (novice operator) Reference exam with the CE-marked FS Exams3 (experienced/expert operator) Exploratory exam with the Research FS Exams4 (experienced/expert operator) Reference exam with the CE-marked FS

Sponsors & Collaborators

  • 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
2022-10-26
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • France

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 NCT05567328 on ClinicalTrials.gov