Evaluation of a Simple-Prep Controlled Embolic

Not Applicable

Recruiting

• Conditions: Embolization; Vascular Tumor; Renal Angiomyolipoma; Renal Cell Carcinoma; Bone Tumor; Portal Vein Embolization
• Interventions: Device: GPX® Embolic Device

• Registration Number: NCT06453642
• Lead Sponsor: Fluidx Medical Technology, Inc.

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.

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-11-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GPX® Embolic Device	GPX® Embolic Device	-

Primary Outcome Measures

Name	Time	Method
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
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 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 Outcome Measures

Name	Time	Method
Occurrence of adjunctive embolization agent usage during the embolization procedure	End of procedure
Occurrence of device-related adverse events (AE) through 30 days post-index procedure	30-day follow-up
Occurrence of catheter occlusion due to the GPX Embolic Material	End of procedure

Trial Locations

Locations (15)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Washington University - Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Mount Sinai; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

MD Anderson Cancer Center - Interventional Radiology; 🇺🇸 Houston, Texas, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Toronto General Hosptial; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital Toronto; 🇨🇦 Toronto, Ontario, Canada

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand