MedTrace Logo

Prostate Embolization for Benign Prostatic Hyperplasia

NCT01924988 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-12-10

Study results available
· View outcomes & findings →

Summary

This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Prostatic Embolization with Embosphere Micropsheres

Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well. The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries.

Sponsors & Collaborators

  • James B. Spies, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01924988 on ClinicalTrials.gov