NCT00926224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

June 22, 2009

Last Update Submit

November 15, 2010

Conditions

Liver FibrosisCirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • diagnosis accuracy for the assement of significant fibrosis and cirrhosis

    at enrollement

Interventions

FibroScan M and XL probesDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Calgary University Hospital

Calgary, Alberta, T2N 4N, Canada

Location

London University Hospital

London, Ontario, N6A 5A5, Canada

Location

Toronto Western General Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Saint-Luc University

Montreal, Quebec, H2X 3J4, Canada

Location

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

CA(5)