Safety and Efficacy of OCL 503 in Prostate Artery Embolization
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|ClinicalTrials.gov Identifier: NCT02509975|
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy||Device: Prostate artery embolization.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
Experimental: Prostate Artery Embolization
Transarterial administration of OCL 503 to the arteries feeding the prostate.
Device: Prostate artery embolization.
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.
- Safety of OCL 503 as measured by Adverse Events reporting. [ Time Frame: 12 months ]Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.
- International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
- Tissue Response [ Time Frame: 12 months ]Measurement in the change in size of the prostate by MRI at 12 months post embolization of the prostatic vasculature with OCL 503.
- Uroflowmetry [ Time Frame: 12 months ]Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.
- International Index of Erectile Function (IIEF) [ Time Frame: 12 months ]Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509975
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Richard Owen, MD||University of Alberta|