NCT02592473

Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

Prostate Artery Embolization Safety and Efficacy: A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Detailed description

This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

Conditions

• Prostatic Hyperplasia
• Benign Prostatic Hyperplasia (BPH)
• Prostatism
• Lower Urinary Tract Symptoms (LUTS)
• Prostatic Hypertrophy
• Hyperplasia
• Male Urogenital Diseases
• Genital Diseases, Male

Interventions

Type	Name	Description
DEVICE	Embozene Microspheres	Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.

Timeline

• Start date: 2015-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2015-10-30
• Last updated: 2019-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study