Evaluation of a Simple-Prep Controlled Embolic

Running, not enrolling · Not applicable

Conditions studied: Embolization, Vascular Tumor, Renal Angiomyolipoma, Renal Cell Carcinoma, Bone Tumor, Portal Vein Embolization

In brief

The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.

Key facts

Study ID

NCT06453642

Run by

Fluidx Medical Technology, Inc.

People needed

114

Starts

2024-11-18

Expected to finish

2026-09-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
• Has undergone an embolization procedure within 30 days prior to consent
• Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
• Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
• Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
• Pregnant, planning to become pregnant during the study period, or breastfeeding
• Unresolved systemic infection or localized infection in the targeted region
• Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
• Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
• Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
• Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
• Intra-procedural exclusion criteria:
• Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions 14. Presence of collateral pathways potentially endangering normal territories during embolization 15. Blood flow precludes safe delivery of embolic material (e.g., arteriovenous shunting or high, unpredictable flow exists) 16. Anatomy that precludes advancement of the delivery device to target vessel embolization site or delivery of embolic material 17. Dissection in the target vessel 18. The delivery device has already been used with an ionic contrast agent (e.g., Conray® (iothalamate meglumine injection USP 60%), Guerbet)

Where it is running

• University of California San Diego Altman Clinical and Translation Research Institute — La Jolla, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Texas Southwestern — Dallas, Texas, United States
• MD Anderson Cancer Center - Interventional Radiology — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• Toronto General Hosptial — Toronto, Ontario, Canada
• Mount Sinai Hospital Toronto — Toronto, Ontario, Canada
• Auckland City Hospital — Auckland, New Zealand
• Christchurch Hospital — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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