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Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

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ClinicalTrials.gov Identifier: NCT00926224
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Cirrhosis Device: FibroScan M and XL probes Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources


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


Primary Outcome Measures :
  1. diagnosis accuracy for the assement of significant fibrosis and cirrhosis [ Time Frame: at enrollement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926224


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

Responsible Party: Celine Fournier, Echosens
ClinicalTrials.gov Identifier: NCT00926224     History of Changes
Other Study ID Numbers: M111
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010

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:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases