Clinical trial NCT06453642: Evaluation of a Simple-Prep Controlled Embolic
Official title: Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Embolization
Vascular Tumor
Renal Angiomyolipoma
Renal Cell Carcinoma
Bone Tumor
Portal Vein Embolization
Keywords: Embolization
Distal Embolization
Distal Vessel Penetration
Peripheral Vasculature
Lead sponsor: Fluidx Medical Technology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2024-06-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Freedom from major adverse events (MAEs)
timeFrame: Index procedure through 30-day follow-up
measure: Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
timeFrame: During procedure
measure: Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
timeFrame: End of procedure
Secondary outcomes:
measure: Occurrence of device-related adverse events (AE) through 30 days post-index procedure
timeFrame: 30-day follow-up
measure: Occurrence of adjunctive embolization agent usage during the embolization procedure
timeFrame: End of procedure
measure: Occurrence of catheter occlusion due to the GPX Embolic Material
timeFrame: End of procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center - Interventional Radiology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto General Hosptial
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital Toronto
state: Ontario
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Michael Darcy, MD
role: PRINCIPAL_INVESTIGATOR
References: