Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Cirrhosis Clinical Trial

Official title:

Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926224
• Other study ID #: M111
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: November 15, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Echosens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cirrhosis
• Liver Fibrosis

Intervention

Device:
• FibroScan M and XL probes
Each patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe

Locations

Country	Name	City	State
Canada	Calgary University Hospital	Calgary	Alberta
Canada	London University Hospital	London	Ontario
Canada	Saint-Luc University	Montreal	Quebec
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Toronto Western General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Echosens

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis accuracy for the assement of significant fibrosis and cirrhosis		at enrollement	No