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

Study acronym: FLIGHT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07470515
Lead Sponsor Medical University Innsbruck
Conditions
(from sponsor)		 Liver Cirrhosis, Refractory Ascites, Variceal Bleeding, Portal Hypertension
Related terms Ascites, Hypertension, Portal, Liver Cirrhosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov