Validation of the New Vibration-guided FibroScan Examination

NACompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

October 26, 2022

Primary Completion Date

December 20, 2024

Study Completion Date

December 20, 2024

Conditions
Liver Diseases
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"

Trial Locations (3)

69495

Hospices Civils de Lyon - Lyon Sud, Lyon

92110

Hôpital Beaujon, Clichy

Unknown

CHU de Nancy, Nancy

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Echosens

INDUSTRY

NCT05567328 - Validation of the New Vibration-guided FibroScan Examination | Biotech Hunter | Biotech Hunter