Status:
COMPLETED
Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Baylis Medical Company
Conditions:
Portal Hypertension
Eligibility:
All Genders
20-99 years
Phase:
NA
Brief Summary
A novel radiofrequency (RF) wire created by Baylis Medical (Montreal, CAN) is an FDA cleared device commonly used for percutaneous recanalization procedures. This wire has an active tip that delivers ...
Detailed Description
The transjugular intrahepatic portosystemic shunt procedure (TIPS), first described in 1969 by Rösch et al., has been widely used to treat the complications of portal hypertension such as recurrent va...
Eligibility Criteria
Inclusion
- Patients with cirrhosis and portal hypertension meeting at least one indication for elective TIPS creation including refractory ascites, acute variceal bleeding not responsive to endoscopic treatment, prevention of recurrent variceal bleeding, portal hypertensive gastropathy, hepatorenal syndrome, Budd-Chiari syndrome, hepatic hydrothorax, hepatic veno-occlusive disease, and hepatopulmonary syndrome.
- Patients who agree to undergo TIPS procedure and participate in this clinical study.
- Age over 20 years
Exclusion
- Patients with a contraindication for TIPS including congestive heart failure, severe tricuspid regurgitation, severe pulmonary hypertension, uncontrolled systemic infection or sepsis and unrelieved biliary obstruction.
- Patients in whom intravascular ultrasound cannot be used because of venous occlusion.
- Decisionally impaired patients
- Need for emergent TIPS creation
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03451149
Start Date
October 25 2017
End Date
January 29 2019
Last Update
November 3 2023
Active Locations (1)
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1
OHSU
Portland, Oregon, United States, 97239