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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04267445
Study type Observational [Patient Registry]
Source University of Calgary
Contact Darshan Bakshi, MD
Phone 4039919257
Email darshan.bakshi@ahs.ca
Status Not yet recruiting
Phase
Start date March 2020
Completion date March 2023

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