Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS)
Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS)
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.
Inclusion Criteria:

 -  Potential participants will be identified in the Urology Clinic diagnosed with benign
 prostatic hypertrophy and fit the criteria -

 1. Have received a diagnosis of BPH with moderate to severe LUTS, as determined by
 IPSS

 2. Are greater than 50 years of age

 3. Have had a pelvic examination by a urologist within the previous 6 months

 4. Have been refractory to medical therapy for 6 months, or have refused medical
 therapy

 5. Have a Qmax below 15 mL/s or acute urinary retention

 6. Prostate larger than 40 cm3

 7. Willing and able to provide written informed consent.

 Exclusion Criteria:

 -  Patients will be excluded from this study if they meet any of the following criteria:

 1. Total serum PSA > 10.0 ng/mL at screening

 2. Advanced atherosclerosis and tortuosity of the iliac arteries

 3. PVR > 250 mL

 4. Use of phytotherapy for BPH within 2 weeks of screening visit

 5. Secondary renal insufficiency (due to prostatic obstruction)

 6. Chronic renal failure (glomerular filtration rate < 60)

 7. Large bladder diverticula or bladder stones

 8. Have claustrophobia or other contraindications to the performance of the pre- and
 post-procedure MRI studies, including but not confined to the presence of metal
 implants, metal plates, bone pins, bone screws, neurostimulators, cardiac
 pacemakers, aneurysm clips, cochlear or retinal implants, or permanent hearing
 aids

 9. Have compromised hematopoietic function (hemoglobin < 100 g/L; lymphocyte count <
 500 x106/L; neutrophil count < 1.5 x 109/L; platelet count < 50 x 109/L

 10. Have had a documented anaphylactic reaction to a drug or anesthetic, or an
 allergic reaction to iodine contrast media not controlled by antihistamines or
 steroids

 11. Have received other investigational drugs or who have had experimental therapy
 within the past 4 weeks or are participating in any other concurrent experimental
 therapy

 12. Have abnormal coagulation profiles

 13. Are allergic to bovine collagen

 14. Are allergic to Perflutren 15 Are unable to comply with the follow up
 requirements of the study 16 Have serious cardiopulmonary compromise