Instylla HES™ Hypervascular Tumor Pivotal Study
The sponsor of this trial, Instylla, Inc. is a privately held company, located in Bedford, MA, focused on developing next-generation liquid embolics for interventional radiology, with initial clinical applications in interventional oncology and peripheral hemostasis.
Investigators at Charlotte Radiology working on this trial:
Principal Investigator- James Chen
Sub-Investigators- Eric Wang, Jeremy Kim, Scott Broadwell, Peter Simon
The study objective is to determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as (i.e., is non-inferior to) standard of care (SOC) transarterial embolization/ conventional transarterial chemoembolization, while resulting in an acceptable risk of the device and procedure-related serious adverse events.
This treatment is indicated for embolization in vessels ≤ 5mm. The primary safety endpoint is freedom from major adverse events through 30 days post-index procedure. The primary effectiveness endpoint is delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by comparing pre and post-procedure angiograms.
Patients will be randomized intra-operatively to the Instylla HES treatment or standard of care (control) at a 2:1 ratio. Participating patients will remain blinded to their study treatment throughout the trial.
About 150 total patients will be enrolled across multiple sites. Charlotte Radiology has screened 3 participants so far and enrolled 2 patients that have completed the study procedure! These procedures using the Hydrogel Embolic System were performed by Dr. James Chen and Dr. Eric Wang.