Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared With Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study
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 device and procedure-related serious adverse events.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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