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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06453642
Other study ID # FLX-CL-5000
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 2026

Study information

Verified date June 2024
Source Fluidx Medical Technology, Inc.
Contact Libble Ginster
Phone 435-893-1555
Email Libble.Ginster@fluidxmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 114
Est. completion date June 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
GPX® Embolic Device
Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fluidx Medical Technology, Inc. Bright Research Partners

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Occurrence of device-related adverse events (AE) through 30 days post-index procedure 30-day follow-up
Secondary Occurrence of adjunctive embolization agent usage during the embolization procedure End of procedure
Secondary Occurrence of catheter occlusion due to the GPX Embolic Material End of procedure
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