Evaluation of a Simple-Prep Controlled Embolic (GPX)

Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Cell Carcinoma; Bone Tumor; Embolization; Renal Angiomyolipoma; Vascular Tumor; Portal Vein Embolization
• Intervention / Treatment: Device: GPX® Embolic Device

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 1Z5
      • Toronto General Hosptial
    • Toronto, Ontario, Canada, M5G 2C4
      • Mount Sinai Hospital Toronto
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
  • Christchurch, New Zealand, 4710
    • Christchurch Hospital
• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego Altman Clinical and Translation Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University - Barnes Jewish Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Carolinas Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center - Interventional Radiology
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GPX® Embolic Device	Device: GPX® Embolic Device; Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major adverse events (MAEs)	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	Index procedure through 30-day follow-up
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)	Determined by the investigator at the time of enrollment	During procedure
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)	Determined by the core lab via comparison of the pre- and final post-embolization images	End of procedure

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fluidx Medical Technology, Inc.
• Collaborators: Bright Research Partners
• Investigators: Principal Investigator: Michael Darcy, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Embolization; Distal Embolization; Distal Vessel Penetration; Peripheral Vasculature
• Additional Relevant MeSH Terms: Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Perivascular Epithelioid Cell Neoplasms; Soft Tissue Neoplasms; Carcinoma, Renal Cell; Bone Neoplasms; Angiomyolipoma; Vascular Neoplasms
• Other Study ID Numbers: FLX-CL-5000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes