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

NCT02592473 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-17

No results posted yet for this study

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).

Conditions

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

Interventions

DEVICE

Embozene Microspheres

Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.

Sponsors & Collaborators

  • Siemens Medical Solutions

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Ziv J Haskal, MD · Professor of Radiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Device
Yes

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 NCT02592473 on ClinicalTrials.gov