MedTrace Logo

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

NCT02575625 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2015-10-16

No results posted yet for this study

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

Conditions

  • Liver Steatosis

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

Sponsors & Collaborators

  • Echosens

    collaborator INDUSTRY

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Frederic PATAT, MD, PhD · CHRU TOURS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • France

Study Locations

More Related Trials

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 NCT02575625 on ClinicalTrials.gov