Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery

NCT ID: NCT01890460

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Trotter, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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013-041

Identifier Type: -

Identifier Source: org_study_id

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