Liver FibrosisNCT00926224
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
A study testing FibroScan M and XL probes in people with Liver Fibrosis and Cirrhosis, run by Echosens at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Cirrhosis
- What is being tested?
- FibroScan M and XL probes
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 5 sitesCanada
- Study dates
- Jul 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Calgary University Hospital
Calgary, Alberta, T2N 4N
London University Hospital
London, Ontario, N6A 5A5
Saint-Luc University
Montreal, Quebec, H2X 3J4
Toronto Western General Hospital
Toronto, Ontario, M5T 2S8
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
About this study
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.
- Conditions
- Liver Fibrosis, Cirrhosis
- Being tested
- FibroScan M and XL probes
- Keywords
- Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis accuracy for the assement of significant fibrosis and cirrhosis
Measured: at enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926224
- Sponsor's protocol ID
- M111
- Status last verified
- Nov 2010
- First submitted
- 22 Jun 2009
- Last updated
- 16 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
- ClinicalTrials.gov ID
- NCT00926224
- Acronym / sponsor ID
- M111
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScan M and XL probesEach patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe | Device | – |
Primary outcome
diagnosis accuracy for the assement of significant fibrosis and cirrhosis
Time frame: at enrollement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan M and XL probes in people with Liver Fibrosis and Cirrhosis, run by Echosens at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis accuracy for the assement of significant fibrosis and cirrhosis (time frame: at enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.