Evaluation of a Simple-Prep Controlled Embolic

Renal Cell Carcinoma Clinical Trial

— GPX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453642
• Other study ID #: FLX-CL-5000
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Angiomyolipoma
• Bone Tumor
• Carcinoma, Renal Cell
• Embolism
• Renal Angiomyolipoma
• Renal Cell Carcinoma

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