Image-guided tiny puncture device to make TIPS safer

Development of Optical Imaging/IVUS-Guided Micropuncture System for TIPS Creation

['FUNDING_R01'] · UNIVERSITY OF WASHINGTON · NIH-11238454

A small, image-guided puncture and balloon catheter being built to help doctors create TIPS shunts more safely for adults and children with severe liver disease, bleeding varices, or fluid buildup (ascites).

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorUNIVERSITY OF WASHINGTON (nih funded)
Locations1 site (SEATTLE, UNITED STATES)
Trial IDNIH-11238454 on ClinicalTrials.gov

What this research studies

This project combines intravascular ultrasound (IVUS) and fiber-optic imaging in a miniature puncture and balloon catheter to guide the needle path during TIPS creation. The device is designed to allow in-plane visualization of the liver tissue and portal vein to reduce blind punctures, radiation exposure, and catastrophic bleeding. Developers are testing the fine needle/balloon catheter in large-animal (pig) models and refining a smaller version that could fit pediatric anatomy. If preclinical results are promising, the device could move toward human feasibility testing at the sponsoring center and partner hospitals.

Who could benefit from this research

Good fit: People with portal hypertension who need TIPS for uncontrolled variceal bleeding, recurrent tense ascites, or worsening kidney function from cirrhosis could be candidates, including children if a pediatric-sized device is available.

Not a fit: Patients without portal hypertension or those who are not surgical/interventional candidates would not benefit from this device, and those already well-managed by medical or endoscopic therapy are unlikely to need it.

Why it matters

Potential benefit: If successful, the device could make TIPS placement safer, cut procedure-related bleeding and complications, lower radiation exposure, and enable pediatric-sized equipment.

How similar studies have performed: Other image-guided and ultrasound-assisted techniques have reduced some TIPS risks, but this specific IVUS plus fiber-optic micropuncture approach is novel and so far mainly tested in animals.

Where this research is happening

SEATTLE, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Conditions: Cancer Treatment

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.