Fibroscan® and Its Dedicated Probes Efficiency in Obese P... | NCT00926224

Studies
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

NCT00926224

Sponsor

Echosens

Status

Completed

Last Update Posted

Nov 16, 2010Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Liver Fibrosis
Cirrhosis

Interventions

FibroScan M and XL probes

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jun 22, 2009

First Submission Date that Met QC Criteria

Jun 22, 2009

First Posted Date

Jun 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2010

Last Update Posted Date

Nov 16, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis accuracy for the assement of significant fibrosis and cirrhosis		at enrollement

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Calgary University Hospital		Calgary	Alberta	T2N 4N	Canada
London University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D005355	Fibrosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided