NCT01890460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

June 27, 2013

Last Update Submit

January 21, 2016

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    on day of surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a liver transplant surgery

You may qualify if:

  • Males and Females over the age of 18
  • Patients undergoing a liver transplant surgery

You may not qualify if:

  • Any person unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Study Officials

  • James Trotter, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 1, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

US(1)