Evaluation of a Simple-Prep Controlled Embolic

NCT ID: NCT06453642

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2026-09-30

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.

Conditions

Embolization; Vascular Tumor; Renal Angiomyolipoma; Renal Cell Carcinoma; Bone Tumor; Portal Vein Embolization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GPX® Embolic Device

Group Type: EXPERIMENTAL

GPX® Embolic Device

Intervention Type: DEVICE

Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

Interventions

GPX® Embolic Device

Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

Intervention Type: DEVICE

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bright Research Partners

INDUSTRY

Sponsor Role: collaborator

Fluidx Medical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Darcy, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

University of California San Diego Altman Clinical and Translation Research Institute

La Jolla, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Indiana University Hospital

Indianapolis, Indiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University - Barnes Jewish Hospital

St 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

Atrium Health Carolinas Medical Center

Charlotte, 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

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hosptial

Toronto, Ontario, Canada

Mount Sinai Hospital Toronto

Toronto, Ontario, Canada

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Countries

United States; Canada; New Zealand

Other Identifiers

FLX-CL-5000

Identifier Type: -

Identifier Source: org_study_id