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Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres

NCT02679430 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-04

No results posted yet for this study

Summary

Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Prostate Arterial Embolization

The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Sergei Sobolevsky, MD · Maimonides Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679430 on ClinicalTrials.gov