Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07470515
NA

Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study

Sponsor: Medical University Innsbruck

View on ClinicalTrials.gov

Summary

Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts. This prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure. Approximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications. The results may help to improve procedural efficiency and radiation safety during TIPS interventions.

Official title: Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-01

Completion Date

2028-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DEVICE

Fiber-Optic Navigation System

Use of a fiber-optic shape sensing navigation system to assist catheter and guidewire navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. The system provides real-time three-dimensional visualization of endovascular devices and is used to support portal vein access during the procedure performed according to routine clinical practice.

Locations (1)

Medical University of Innsbruck

Innsbruck, Tyrol, Austria