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Embosphere® PROstate Post Market Study — PROstate  

Benign Prostatic Hyperplasia Clinical Trial

Official title:
A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres

Clinical Trial Summary

Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Clinical Trial Description

This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months and 24 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03527589
Study type Observational [Patient Registry]
Source Merit Medical Systems, Inc.
Contact
Status Completed
Phase
Start date August 16, 2018
Completion date January 22, 2022
View Details
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