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Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Echosens
ClinicalTrials.gov Identifier:
NCT00926224
First received: June 22, 2009
Last updated: November 15, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Liver Fibrosis
Cirrhosis
 Device: FibroScan M and XL probes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Echosens:

Primary Outcome Measures:
  • diagnosis accuracy for the assement of significant fibrosis and cirrhosis [ Time Frame: at enrollement ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926224

Locations
Canada, Alberta
Calgary University Hospital
Calgary, Alberta, Canada, T2N 4N
Canada, Ontario
London University Hospital
London, Ontario, Canada, N6A 5A5
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Toronto Western General Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Saint-Luc University
Montreal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Echosens
  More Information

No publications provided

Responsible Party: Celine Fournier, Echosens
ClinicalTrials.gov Identifier: NCT00926224     History of Changes
Other Study ID Numbers: M111
Study First Received: June 22, 2009
Last Updated: November 15, 2010
Health Authority: Canada: Health Canada

Keywords provided by Echosens:
Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013