NCT06453642

Evaluation of a Simple-Prep Controlled Embolic

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Fluidx Medical Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2024-06-11
• Last updated: 2026-03-30

Locations

20 sites across 3 countries: United States, Canada, New Zealand

Regulatory

• FDA-regulated device study