Evaluation of a Simple-Prep Controlled Embolic

Launched by FLUIDX MEDICAL TECHNOLOGY, INC. · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new device called the GPX® Embolic Device, which is designed to block blood flow to certain areas in the body, a process known as embolization. The goal is to see how safe and effective this device is for patients with conditions like vascular tumors, renal issues, or portal vein problems. The study will involve about 114 participants and will take place at up to 25 locations across the USA, New Zealand, and Canada.

To be eligible for this trial, participants must be at least 18 years old and have a medical need for embolization in areas such as the kidneys or vascular tumors. They should also expect to stay in good health for at least 30 days after the procedure. Participants will be asked to provide consent and follow specific guidelines throughout the study. Those with certain medical conditions, recent embolization procedures, or who are pregnant or breastfeeding will not be eligible. If you join this trial, you can expect to receive close monitoring and care to ensure your safety and well-being during the process.

Gender

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Eligibility 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)