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COMPLETED
NCT02575625
NA

Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

Summary

Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition. This proof of concept validation is made up of two steps: * Step 1: feasibility study of the method on 10 healthy volunteers * Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in: * Fibroscan measure, preceded by tracking ultrasonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2013-04

Completion Date

2015-11

Last Updated

2026-06-15

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Fibroscan

Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.

BIOLOGICAL

Blood test for biological assessment of liver function

Blood test for biological assessment of liver function

DEVICE

MRI

Liver MRI

Locations (1)

University Hospital of Tours

Tours, France