Evaluation of a Simple-Prep Controlled Embolic

NCT06453642 | Active Not Recruiting DMC FDA Device

• 1 other identifier: FLX-CL-5000
• Study Type: interventional
• Target: 114
• Locations: 3 countries
• Sites: 20

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.

Conditions

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

Keywords

Embolization; Distal Embolization; Distal Vessel Penetration; Peripheral Vasculature

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

GPX® Embolic Device

EXPERIMENTAL

Device: GPX® Embolic Device

Interventions

GPX® Embolic Device DEVICE

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

GPX® Embolic Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years on the date of consent
• Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
• 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
• Informed consent granted by the patient or legally authorized representative
• Willing and able to comply with the protocol-specified procedures and assessments

You may not qualify if:

• 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
• Has undergone an embolization procedure within 30 days prior to consent
• Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
• Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
• Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
• Pregnant, planning to become pregnant during the study period, or breastfeeding
• Unresolved systemic infection or localized infection in the targeted region
• 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
• 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
• 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)
• 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
• \. 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)

Sponsors & Collaborators

• Fluidx Medical Technology, Inc.: lead
• Bright Research Partners: collaborator

Study Sites (20)

University of California San Diego Altman Clinical and Translation Research Institute

La Jolla, California, 92037, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center - Interventional Radiology

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hosptial

Toronto, Ontario, M5G 1Z5, Canada

Location

Mount Sinai Hospital Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

Auckland City Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

MeSH Terms

Conditions

Vascular Neoplasms; Angiomyolipoma; Carcinoma, Renal Cell; Bone Neoplasms

Condition Hierarchy (Ancestors)

Soft Tissue Neoplasms; Neoplasms by Site; Neoplasms; Vascular Diseases; Cardiovascular Diseases; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Perivascular Epithelioid Cell Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael Darcy, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: November 18, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); CA (3); US (15)