Evaluation of Liver Disease With Elastography Measurement... | NCT01890460

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

NCT01890460

Sponsor

Baylor Research Institute

Status

Completed

Last Update Posted

Jan 22, 2016Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Liver Transplantation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jun 27, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jul 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2016

Last Update Posted Date

Jan 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing a liver transplant surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Trotter, MD	Baylor Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	75246	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided