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Clinical Trials/NCT01890460
NCT01890460
Completed
Not Applicable

Quantitative Evaluation of Liver Disease With Liver Elastography Measurements Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine in Patients Undergoing Liver Transplant Surgery

Baylor Research Institute1 site in 1 country13 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Transplantation
Sponsor
Baylor Research Institute
Enrollment
13
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
July 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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