Benign Prostatic Hyperplasia Clinical Trial
Official title:
A Prospective Single Centre Study to Evaluate the Safety and Effectiveness of Using Contrast Enhanced Ultrasound and Echogenic Embolic Agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy
A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia
Single center, open label, pilot study. After screening and baseline testing, eligible
patients will undergo transarterial embolization of the prostatic vasculature. Each patient
will undergo a single embolization procedure.
After completion of treatment in the first 2 patients and a review of follow-up assessments
after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the
first 2 patients. Patients will be enrolled until 15 patients have undergone treatment. The
patients will undergo MRI, contrast enhanced ultrasound and computerized tomography (CT)
angiograpy/intra-procedural cone beam CT as required.
Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic
Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign
Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast
Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time
of embolization.
Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in
central gland enhancement characteristics using 3D volume assessment software.
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