Embosphere PROstate Post Market Study
Research type
Research Study
Full title
A Prospective Post Market Study of Patients with Symptomatic Benign Prostatic Hyperplasia treated by Prostatic Artery Embolization with Embosphere® Microspheres
IRAS ID
250347
Contact name
Mark Little
Contact email
Sponsor organisation
Merit Medical Systems Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
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 1,000 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 IPSS score at baseline, 3 months, 12 months, 24 months and 36 months. Safety will be assessed by evaluating treatment 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 SHIM score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/2065
Date of REC Opinion
17 Dec 2018
REC opinion
Further Information Favourable Opinion