An observational study in Benign Prostatic Hyperplasia, sponsored by University of Calgary. Status unknown. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by University of Calgary · Observational
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 15 is below the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men over 50 who have been diagnosed with benign prostatic hyperplasia and their prostates are larger than 40 cm3.
Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -
Exclusion Criteria:
Patients will be excluded from this study if they meet any of the following criteria:
Single center, open label, pilot study. 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. 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.
Procedure: Embolization of prostatic artery under ultrasound guidance
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.
Dimensions of prostate
Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique
Time frame: One year
Symptoms of benign prostate hyperplasia
Evaluate the efficacy of using contrast enhanced ultrasound and echogenic embolization agent Ekobi Embolization Microspheres on International Prostate Symptom Score (IPSS).
Time frame: One year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Calgary