Evaluation of a Simple-Prep Controlled Embolic

Trial Title: Evaluation of a Simple-Prep Controlled Embolic

NCT ID: NCT06453642

Condition: Embolism
Vascular Tumor
Renal Angiomyolipoma
Renal Cell Carcinoma
Bone Tumor
Portal Vein Embolism

Conditions: Official terms:
Carcinoma, Renal Cell
Angiomyolipoma
Embolism

Conditions: Keywords:
Embolization
Distal Embolization
Distal Vessel Penetration
Peripheral Vasculature

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: GPX® Embolic Device
Description: Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches
Arm group label: GPX® Embolic Device

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Auckland City Hospital

Address:
City: Auckland
Country: New Zealand

Status: Recruiting

Contact:
Last name: Cynthia Corne

Phone: +64 9 307 4949

Phone ext: 21505
Email: CorneC@adhb.govt.nz

Contact backup:
Last name: Divina Ofren
Email: DivinaO@adhb.govt.nz

Investigator:
Last name: Andrew Holden
Email: Principal Investigator

Start date: September 2024

Completion date: June 2026

Lead sponsor:
Agency: Fluidx Medical Technology, Inc.
Agency class: Industry

Collaborator:
Agency: Bright Research Partners
Agency class: Industry

Source: Fluidx Medical Technology, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06453642