- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890460
Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery (SupersonicOR)
January 21, 2016 updated by: Baylor Research Institute
Quantitative Evaluation of Liver Disease With Liver Elastography Measurements Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine in Patients Undergoing Liver Transplant Surgery
The purpose of the study is to compare ultrasound measurements of the liver obtained prior to surgery on the skin to measurements obtained during surgery directly on the diseased liver.
The objective is to determine if ultrasounds of the liver on the skin can provide accurate measurements of disease of the liver to provide an alternative option to liver biopsies.
Study Overview
Status
Completed
Conditions
Detailed Description
A non-invasive, ultrasound platform based, ShearWaveTM Elastography measurement will be obtained at two time points on each qualified patient.
The first time point will be in the operating room before the initial incision is made.
The second time point involves placement of a small, hand-held modified ultrasound probe directly on the patient's diseased liver during the liver transplant surgery.
The probe used in this study is the SuperCurved™SC6-1, capable of a band width of 1-6MHz with 192 elements.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75246
- Baylor University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing a liver transplant surgery
Description
Inclusion Criteria:
- Males and Females over the age of 18
- Patients undergoing a liver transplant surgery
Exclusion Criteria:
- Any person unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To obtain quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in patients undergoing a liver transplant surgery.
Time Frame: on day of surgery
|
on day of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (ESTIMATE)
July 1, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 22, 2016
Last Update Submitted That Met QC Criteria
January 21, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 013-041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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