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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
Bland TAE or cTACE
UAB Hospital
Birmingham, Alabama, United States
Central Arkansas Radiation Therapy Institute, Inc.
Little Rock, Arkansas, United States
Primary Effectiveness Endpoint: Delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by an independent radiologist via comparison of the pre and final post procedure images
Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel
Time frame: Immediately post-embolization procedure
Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure
Time frame: 30 days post-embolization procedure
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