Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-03 @ 4:06 PM
Study NCT ID:
NCT01644656
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
Sponsor:
VA Connecticut Healthcare System
Organization:
Study Overview
Official Title:
Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
Status:
COMPLETED
Status Verified Date:
2018-09
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:
None
Brief Summary:
The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.
Detailed Description:
DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.
METHODOLOGY
* The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
* Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.
METHODOLOGY
* The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
* Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.
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?: