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Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Primary Purpose

Liver Fibrosis, Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FibroScan M and XL probes
Sponsored by
Echosens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary University Hospital
  • London University Hospital
  • Toronto Western General Hospital
  • Toronto Liver Centre
  • Saint-Luc University

Outcomes

Primary Outcome Measures

diagnosis accuracy for the assement of significant fibrosis and cirrhosis

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
November 15, 2010
Sponsor
Echosens
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1. Study Identification

Unique Protocol Identification Number
NCT00926224
Brief Title
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Official Title
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Echosens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Cirrhosis
Keywords
Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
FibroScan M and XL probes
Intervention Description
Each patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe
Primary Outcome Measure Information:
Title
diagnosis accuracy for the assement of significant fibrosis and cirrhosis
Time Frame
at enrollement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Calgary University Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N
Country
Canada
Facility Name
London University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto Western General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Saint-Luc University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada

12. IPD Sharing Statement

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