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OpenTrials
Completed

NCT Number: NCT00926224

Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

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.

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Key information

Conditions

Liver Fibrosis Cirrhosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calgary University Hospital, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FibroScan M and XL probes

Device

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

Primary outcomes

  1. diagnosis accuracy for the assement of significant fibrosis and cirrhosis

    Time frame: at enrollement

Sponsors and collaborators

Lead sponsor

Echosens

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2009
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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