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Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)

Primary Objective

To evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration.

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Description

The GPX Embolic Device is only intended for distal embolization in the peripheral vasculature including vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors), renal embolization, and portal vein branches. It is not intended for embolization of active bleeding sites, veins other than the portal vein, aneurysms, endoleaks, vascular malformations, or vessels for flow redistribution.

Details
Age
Adult
Eligibility
Patients must meet all the following inclusion criteria: 1. Age ≥18 years on the date of consent 2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits 3. Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including: o Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors) o Renal embolization o Portal vein branches 4. Informed consent granted by the patient or legally authorized representative 5. Willing and able to comply with the protocol-specified procedures and assessments
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Lisa Walker

Lisa Walker

Study ID

Protocol Number: 24-0127

More information available at ClinicalTrials.gov: NCT06453642

Categories

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