Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01890460
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2013-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SupersonicOR
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: