Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire

Completed · Not applicable

Conditions studied: Portal Hypertension

In brief

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 focused RF energy and has been applied for many procedures such as percutaneous transseptal left heart access, recanalization of central vein occlusion, recanalization of arterial occlusion, and recanalization of bile duct occlusion. There has been no study investigating the use of the RF wire for TIPS creation in clinical practice with humans. Having promising results of an experimental feasibility investigation in swine, the investigators are seeking to assess the feasibility and safety of the RF wire to cut through tissue in the liver while creating TIPS in the clinical setting.

Key facts

Study ID

NCT03451149

Run by

Oregon Health and Science University

People needed

10

Starts

2017-10-25

Expected to finish

2019-01-29

Last updated by the study team

2023-11-03

Who can join

Age: 20 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OHSU — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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