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Evaluation of a new embolic device for treating vascular tumors and renal conditions

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

Not applicable Interventional Fluidx Medical Technology, Inc. · NCT06453642

This study is testing a new device to see if it can safely and effectively help treat patients with certain vascular tumors and kidney conditions during a procedure called embolization.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment114 (estimated)
Ages18 Years and up
SexAll
SponsorFluidx Medical Technology, Inc. Industry-sponsored
Locations15 sites (Aurora, Colorado and 14 other locations)
Trial IDNCT06453642 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the GPX® Embolic Device for distal vessel penetration during embolization procedures in patients with vascular tumors, renal angiomyolipoma, renal cell carcinoma, and other related conditions. It is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study involving 114 subjects across up to 25 investigational sites in the USA, New Zealand, and Canada. Participants will undergo the embolization procedure and will be monitored for 30 days post-procedure to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require peripheral embolization for vascular tumors or renal conditions and can comply with follow-up assessments.

Not a fit: Patients requiring embolization for neurovasculature, coronary vasculature, or non-tumoral bleeding sites will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with vascular tumors and renal conditions requiring embolization.

How similar studies have performed: Other studies have shown success with similar embolization approaches, indicating potential for this method to be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Aurora, Colorado and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EmbolizationVascular TumorRenal AngiomyolipomaRenal Cell CarcinomaBone TumorPortal Vein EmbolizationDistal EmbolizationDistal Vessel Penetration
Last reviewed 2026-06-10 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.