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

NCT03451149 | Completed DMC FDA Device

• 1 other identifier: OHSU eIRB # 16296
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Portal Hypertension

Keywords

TIPS

Outcome Measures

Primary Outcomes (2)

• Feasibility to use the device as anticipated

  Ability of the device to perform as anticipated

  within 24 hours

• Incidence of device-related adverse events (Safety)

  No device-related adverse events

  within 24 hours

Secondary Outcomes (2)

• Penetrating ability

  within 24 hours

• Device use as a standard working wire

  within 24 hours

Study Arms (1)

Intervention

EXPERIMENTAL

Undergo transjugular intrahepatic portosystemic shunt creation using a radiofrequency wire (Powerwire) in lieu of a trocar needle to cut through liver parenchyma

Device: Radiofrequency wire (Powerwire)

Interventions

Radiofrequency wire (Powerwire) DEVICE

Using a radiofrequency wire in lieu of a needle for penetrating the liver during transjugular intrahepatic portosystemic shunt creation.

Intervention

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Baylis Medical Company: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Khashayar Farsad, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A single group of up to 10 participants will be enrolled to evaluate a radiofrequency wire for cutting through liver parenchyma instead of the standard trocar needle during transjugular intrahepatic portosystemic shunt creation. This will be to test this device for feasibility and not health outcomes.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 1, 2018
• Study Start: October 25, 2017
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anytime after study completion, per approved IRB protocol
• Access Criteria: IRB-approved protocols for access to data only

Locations

US (1)