Evaluation of Liver Disease With Elastography Measurements 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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: SupersonicOR

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 1, 2013
Registry last updated: Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed