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Clinical Trials in Canada / NCT06453642
Active, not recruiting Not applicable

Evaluation of a Simple-Prep Controlled Embolic

NCT06453642 · tracked via the Priya Life Science Canada tracker
Sponsor
Fluidx Medical Technology, Inc
Phase
Not applicable
Started
2024-11-18
Last updated
2026-03-30

Condition(s) studied

EmbolizationVascular TumorRenal AngiomyolipomaRenal Cell CarcinomaBone TumorPortal Vein Embolization

Investigational drug(s) / intervention(s)

GPX® Embolic Device

GPX® Embolic Device: Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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: * Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors) * Renal embolization * 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 Exclusion Criteria: 1. 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 2. Has undergone an embolization procedure within 30 days prior to consent 3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine) 4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents) 5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated 6. Pregnant, planning to become pregnant during the study period, or breastfeeding 7. Unresolved systemic infection or localized infection in the targeted region 8. 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 9. 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 10. 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) 11. 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: 13\. 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)

Primary outcome measure(s)

Trial sites (20)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06453642 on ClinicalTrials.gov ↗ ← All trials in Canada