Benign Prostatic Hyperplasia Clinical Trial
Official title:
An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy
This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.
Prior to entering the study, all patients will undergo pre-study assessments including
compliance with inclusion and exclusion criteria, laboratory assessments, IPSS, uroflowmetry,
IIEF, and MRI pelvic imaging. Following conventional catheter angiography with cone-beam CT
to confirm catheter placement and prostatic vasculature, each patient will undergo
transarterial embolization with OCL 503. OCL 503 will be administered intra-arterially via
microcatheter until there is stasis of blood flow.
Patient assessments include blood work, IPSS, uroflowmetry, IIEF, MRI and patient interviews
conducted at 3 months, 6 months, and 12 months post embolization.
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