Prospective, Cross-sectional and Multicenter Study, Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease Using Liver Biopsy as Reference.

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Recruitment status:
Recruiting
Primary Sponsor:
Echosens
Recruitment countries:
United Kingdom
Health condition studied:
Non-alcoholic Fatty Liver Disease
URL:
Link to the clinical trial website

About the trial

Interventions:
Device: FibroScan® examination.
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - Patients must be at least 18 years of age

    - Patients must be able to give written informed consent

    - Patients with suspected NAFLD

    - Patients scheduled to have a liver biopsy within 2 weeks of Fibroscan examination

    - HBsAg negative, Anti-HCV negative, HCV-RNA negative, HBV-DNA negative

    Exclusion Criteria:

    - Unable or unwilling to provide written informed consent

    - Patients with ascites

    - Pregnant women

    - Patients with any active implantable medical device (such as pacemaker or
    defibrillator)

    - Patients who have had a liver transplant

    - Patients with cardiac failure and/or significant valvular disease

    - Patients with hematochromatosis

    - Refusal to undergo a liver biopsy and/or blood test

    - Alcohol consumption above recommended limits (>14 units/week for women and >21
    units/week for men)

    - Confirmed diagnosis of active malignancy, or other terminal disease

    - Patient participation in another clinical trial within the preceding 30 days
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Performance of CAP will be assessed using ROC analysis for the detection of steatosis above 5% - 10% - 30% and 60% using liver biopsy as the reference.
Secondary outcomes:
Clinical, histological and biological factors associated CAP will be assessed using multivariate correlation.
Target sample size:
450
Study type:
Interventional
Study design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Contacts:

Technical details

Scientific title:
Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease (NAFLD)Using Liver Biopsy as Reference.
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT01985009
Secondary ID:
M118
Register:
ClinicalTrials.gov
Date of registration:
31/10/2013
Date of first enrollment:
January 2014
Last refreshed:
15 August 2016

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