Bone Tumor, Embolization, Portal Vein Embolization, Renal Angiomyolipoma, Renal Cell Carcinoma, Vascular Tumor
Conditions
Keywords
Embolization, Distal Embolization, Distal Vessel Penetration, Peripheral Vasculature
Brief 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.
Detailed description
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects will undergo distal embolization in the peripheral vasculature, including vascular tumors, renal embolizations, and portal vein branches, with the GPX® Embolic Device and will then be followed 30-days post-procedure.
Interventions
DEVICEGPX® Embolic Device
Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches
Sponsors
Fluidx Medical Technology, Inc.
Bright Research Partners
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major adverse events (MAEs) | Index procedure through 30-day follow-up | MAEs are defined as: * Nontarget embolization with ischemia in an unintended anatomical area * Systemic allergic and/or toxic reaction to the GPX Embolic Device * Catheter entrapment and/or breakage * Culture-proven abscess in target organ/tissue * Embolization-related death |
| Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s) | During procedure | Determined by the investigator at the time of enrollment |
| Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s) | End of procedure | Determined by the core lab via comparison of the pre- and final post-embolization images |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of device-related adverse events (AE) through 30 days post-index procedure | 30-day follow-up |
| Occurrence of adjunctive embolization agent usage during the embolization procedure | End of procedure |
| Occurrence of catheter occlusion due to the GPX Embolic Material | End of procedure |
Countries
Canada, New Zealand, United States
Contacts
PRINCIPAL_INVESTIGATORMichael Darcy, MD
Washington University School of Medicine
Outcome results
None listed