Status:

COMPLETED

Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Lead Sponsor:

Echosens

Conditions:

Liver Fibrosis

Cirrhosis

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2010

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00926224

Start Date

July 1 2009

End Date

September 1 2010

Last Update

November 16 2010

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Calgary University Hospital

Calgary, Alberta, Canada, T2N 4N

2

London University Hospital

London, Ontario, Canada, N6A 5A5

3

Toronto Western General Hospital

Toronto, Ontario, Canada, M5T 2S8

4

Toronto Liver Centre

Toronto, Ontario, Canada, M6H 3M1