Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Not Applicable
Completed
- Conditions
- Liver FibrosisCirrhosis
- Registration Number
- NCT00926224
- Lead Sponsor
- Echosens
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method diagnosis accuracy for the assement of significant fibrosis and cirrhosis at enrollement
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Calgary University Hospital
🇨🇦Calgary, Alberta, Canada
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
London University Hospital
🇨🇦London, Ontario, Canada
Toronto Western General Hospital
🇨🇦Toronto, Ontario, Canada
Saint-Luc University
🇨🇦Montreal, Quebec, Canada