Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

NCT ID: NCT00926224

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Fibrosis Cirrhosis

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Echosens

INDUSTRY

Sponsor Role lead

Responsible Party

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Echosens

Locations

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Calgary University Hospital

Calgary, Alberta, Canada

Site Status

London University Hospital

London, Ontario, Canada

Site Status

Toronto Western General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Liver Centre

Toronto, Ontario, Canada

Site Status

Saint-Luc University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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M111

Identifier Type: -

Identifier Source: org_study_id