Last updated on June 2019

Embosphere PROstate Post Market Study

Brief description of study

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.

Detailed Study 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 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 International Prostate Symptom Score (IPSS) 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 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.

Eligibility Criteria Inclusion Criteria

  • Patient has signed informed consent
  • Patient age is 18 years or older at time of informed consent
  • Patient will undergo PAE with Embosphere Microspheres for the treatment of symptomatic BPH with LUTS

Exclusion Criteria

  • Patient is unable or unwilling to provide follow-up information
  • Patient is undergoing PAE for reasons that do not include symptomatic BPH with LUTS
  • Any other reason the investigator deems cause for exclusion

A treatment-related adverse event is defined in this post market study as any event that began on or after the date of the PAE procedure and is considered related to the study procedure by the investigator. All related events must be reported in the case report form and followed until resolution.Any treatment-related serious adverse events (SAE) that occurs on or after the date of the PAE or worsened in severity or frequency after the PAE must be reported to the Sponsor immediately (not to exceed 24 hours within site notification of the event) in the case report form or via email. It is the responsibility of Investigators to inform their Review Board/ Ethics Committee (IRB/EC) of complications or serious injury as required by their Institutional Review Board/ Ethics Committee (IRB/EC) procedure and/or federal law.

After the study has been fully explained, written informed consent will be obtained from either the patient or his guardian or legal representative prior to any study procedures. The method of obtaining and documenting the informed consent and the contents of the consent will comply with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and all applicable regulatory requirement(s).

Clinical Study Identifier: NCT03527589

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