Phase
Condition
Liver Disease
Liver Disorders
Diabetes And Hypertension
Treatment
Scorpion Portal Vein Access Kit
Cook Transjugular Liver Access Set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥ 18 years of age at the time of the TIPS procedure
TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/orhydrothorax
Willing and able to provide written informed consent and HIPAA (Health InsurancePortability and Accountability Act) authorization
Willing and able to comply with the study procedures and follow up schedule
Exclusion
Exclusion Criteria:
Known active malignancy
MELD score ≥ 18 at time of screening
History of polycystic liver disease
Active bleeding from any source
Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right toleft cardiopulmonary shunt
Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of themain or target portal vein on prior CT examination
Active or uncontrolled hepatic encephalopathy
Systemic infection/sepsis
Biliary obstruction
Uncorrectable coagulopathy
Any diminutive or partially thrombosed right portal vein
Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
Pregnant women or women who are planning to become pregnant
Study Design
Connect with a study center
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
New York Presbyterian - Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
New York Presbyterian - Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
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