NCT02396420

Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: South Florida Medical Imaging, PA · Academic / Other
• Sex: Male
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Detailed description

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Embosphere Microspheres

Timeline

• Start date: 2015-09-24
• Primary completion: 2016-11-17
• Completion: 2016-11-17
• First posted: 2015-03-24
• Last updated: 2018-11-06
• Results posted: 2018-11-06

Locations

1 site across 1 country: United States