GPX Embolic Device Study Experience: Embolization of Renal Tumors in Two Patients

Purpose: GPX is a novel embolic agent designed for embolization procedures, including transcatheter embolizations. The material is a low-viscosity fluid before delivery and solidifies in response to physiological ionic strength. The material is produced in two configurations, a lower viscosity GPX-LV designed for deep penetration and a higher viscosity GPX-HV designed for proximal delivery and conjunctive use with a coil. Preclinical studies have demonstrated long-term occlusion without recanalization and desirable handling characteristics. A clinical study is ongoing to study the use of GPX Embolic Device in the peripheral vasculature, including interventional radiology and interventional oncology applications. The primary objectives of this study are to evaluate safety and early indicators of performance for the GPX Embolic Device and to provide direction for developing a pivotal clinical trial.

Materials and Methods: This is a single-arm, multicenter, open label, nonrandomized, prospective, first-in-human feasibility study evaluating the use of the GPX Embolic Device in the peripheral vasculature. Trial enrollment consists of 20 participants with various clinical needs appropriate for peripheral embolization. Technical success (including imaging follow-up, if available), freedom from adverse events, and handling or performance characteristics are being assessed.

Results: Early case study results will be presented, including embolizations of renal tumors to treat hematuria. In these cases, GPX exhibited good visibility and fully embolized the targeted vessels, showing good filling of targeted distal branches and of the tumor blush. Target regions were fully occluded at the first angiogram (taken immediately after delivery), and the procedures were considered technical successes. Procedural and follow-up results from these cases, including resolution of hematuria, will be presented.

Conclusions: Early clinical cases with the GPX Embolic Device have been promising, with these cases meeting the desired clinical endpoints. A larger pivotal study is planned.