Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Echosens North America

Status

Completed

Conditions

Cirrhosis

Liver Fibrosis

Treatments

Device: FibroScan M and XL probes

Study type

Interventional

Funder types

Industry

Identifiers

NCT00926224

M111

Details and patient eligibility

About

The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients > 28 kg/m² with various liver diseases in patients with chronic liver disease scheduled for a liver biopsy.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient of at least 18 years of age
Patient able to give written informed consent form
Patient with a BMI superior or equal to 28kg/m²
Patient scheduled to have a liver biopsy within 1 month after the enrollment or with a liver biopsy performed within 6 months before the enrollment.
Patient for which abdominal ultrasound is technically possible

Exclusion criteria

Unable or unwilling to provide written informed consent
Confirmed diagnosis and/or history of malignancy, or other terminal disease
Patients with clinical ascites
Pregnant women
Patient with a BMI < 28 kg/m²
Patients with any active implantable medical device (such as pacemaker or defibrillator)
Transplanted patient and patient with heart disease
Refusal to undergo a liver biopsy