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Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia

NCT04236687 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Holmium laser enucleation of the prostate

Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra

PROCEDURE

Artery embolization of the prostate

A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Fernando Agreda, MD · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-02-01
Completion
2022-02-01

Countries

  • Spain

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 NCT04236687 on ClinicalTrials.gov