Liver DiseaseNCT02070315
Quantitative Evaluation of the Progression of Liver Disease, Using ShearWaveTM
An observational study of Liver Disease and Heart Failure, run by Baylor Research Institute at 1 site in United States.
Trial summary
Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Heart Failure
- How many people
- 1,247 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 28 Apr 2022
- Phase
- Observational
- 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
Study population: participants will be from Liver Consultants of Texas patient population
Who may be able to join
- Males and Females over the age of 18
- Patients of Liver Consultant's of Texas Dallas office, with chronic liver disease or liver transplant patient seen in Liver Transplant Clinic
- Patients diagnosed with heart failure
Who cannot join
- Any person unable to provide an informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Quantitative Evaluation of Liver Disease With Liver and Kidney Elastography Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine
Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.
Read the detailed description
To obtain a quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine.
To compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in post-liver transplantation patients.
- Conditions
- Liver Disease, Heart Failure
- Keywords
- heart failure, liver failure, post liver transplant
- Medical subject headings
- Liver Diseases, Heart Failure, Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Shearwave Elastography Ultrasound
Patients will have a scan performed at their regularly scheduled clinic visits.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2012
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Trotter, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070315
- Sponsor's protocol ID
- 012-011
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2013
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Liver Disease With Liver and Kidney Elastography Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine
- ClinicalTrials.gov ID
- NCT02070315
- Acronym / sponsor ID
- 012-011
- Conditions
- Liver Disease, Heart Failure
- Keywords
- heart failure, liver failure, post liver transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 25 Feb 2014 (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.
Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.
Detailed description
To obtain a quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine.
To compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in post-liver transplantation patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants will be from Liver Consultants of Texas patient population
Key inclusion criteria (3 listed)
- Males and Females over the age of 18
- Patients of Liver Consultant's of Texas Dallas office, with chronic liver disease or liver transplant patient seen in Liver Transplant Clinic
- Patients diagnosed with heart failure
Key exclusion criteria (1 listed)
- Any person unable to provide an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shearwave Elastography Ultrasound
Time frame: 1 day
Patients will have a scan performed at their regularly scheduled clinic visits.
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 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
James Trotter, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease and Heart Failure, run by Baylor Research Institute at 1 site in United States.
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 3 inclusion and 1 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Shearwave Elastography Ultrasound (time frame: 1 day). 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 27 Jan 2026.