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SHAPE for Portal Hypertension Estimation
NCT02489045Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2015
- Primary completion
- Mar 2019
- Countries
- 1
- Sponsor
- Thomas Jefferson University
- Modality
- Nanoparticles
- Drugs
- sonazoid
- Conditions
- Portal Hypertension (PH)
01
Overview
Phase 4, open-label, single-arm trial of sonazoid in Portal Hypertension (PH), sponsored by Thomas Jefferson University. Primary endpoints: Diagnostic Accuracy of SHAPE Liver Pressure Estimates for Diagnosing Portal Hypertension With Catheter Pressure Measurements as the Reference Standard at 1 day, SHAPE Liver Pressure Estimates Correlation With Catheter Pressure Measurements at 1 day and 1 more. Started Apr 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
SHAPE measurement
Sonazoid contrast-enhanced ultrasound using SHAPE algorithm
03
Who it enrols
Adult patients scheduled for trans-jugular liver biopsy, excluding those with severe cardiopulmonary conditions, pregnancy, or egg allergies.
04
Endpoints
Primary
Diagnostic Accuracy of SHAPE Liver Pressure Estimates for Diagnosing Portal Hypertension With Catheter Pressure Measurements as the Reference Standard
SHAPE Liver Pressure Estimates Correlation With Catheter Pressure Measurements
Comparing SHAPE Results With Blood Work and Concomitant Imaging in Portal Hypertension Patients
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