CClinicalTrials.gg
Sign In
Status unknownNCT02592473Updated Apr 17, 2019

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

An interventional study of Embozene Microspheres in Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH) and Prostatism, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by University of Virginia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
45 Years to 80 Years
Sex
Male
01

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).

Read the detailed description

This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

02

Conditions studied

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

Keywords

  • Prostate Artery Embolization (PAE)
  • Benign Prostatic Hyperplasia (BPH)
  • Lower Urinary Tract Symptoms (LUTS)
  • BPH
  • PAE
  • LUTS
  • Prostatic Artery Embolization
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 50 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients between ages 45-80 years
  • Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
  • IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of \<12mL/s (milliliters per second) .
  • All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging

Exclusion criteria

Exclusion Criteria:

  • Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
  • Cases of biopsy proven prostate cancer or urethral cancer.
  • Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
  • Patients who are classified as New York Heart Association Class III (Moderate), or higher.
  • Patients with history of prior pelvic irradiation.
  • Hypersensitivity reactions to contrast material not manageable with prophylaxis.
  • Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Embozene Microspheres

    Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate.

    Device: Embozene Microspheres

Interventions

  • DeviceEmbozene Microspheres

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

06

What researchers measure

Primary outcomes

  1. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax (peak urinary flow rate) assessment

    Time frame: 12 months

  2. Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures

    Time frame: 2 weeks

  3. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax assessment

    Time frame: 24 months

  4. Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures

    Time frame: 24 months

  5. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    IPSS (International Prostate Symptom Score)

    Time frame: 12 months

  6. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    IPSS

    Time frame: 24 months

  7. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QoL(quality of life question)

    Time frame: 12 months

  8. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QoL

    Time frame: 24 months

  9. Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax

    Time frame: 24 months

Secondary outcomes

  1. Urine flow rate as measured by QMax

    Time frame: 1 month

  2. Urine flow rate as measured by QMax

    Time frame: 24 months

  3. Post-void residual measured in ml/cc

    Time frame: 1 month

  4. Post-void residual measured in ml/cc

    Time frame: 24 months

  5. UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score

    Time frame: 1 month

  6. UCLA-PCI-SF score

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • University of Virginia Health Systems
    Charlottesville, Virginia 22908, United States
    • Joshua Feazell, BS · Contact · jf9rf@virginia.edu · 434-297-5682
    • Brigitte J Kelly, BSN RN CCRC · Contact · bjk3c@virginia.edu · 434-297-7136
    • Ziv J Haskal, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02592473
Lead sponsor
University of Virginia
Collaborators
Siemens Medical Solutions
Responsible party
Ziv Haskal, MD (Principal Investigator, University of Virginia) — Principal investigator
First posted
Oct 30, 2015
Start date
Nov 2015
Primary completion
Nov 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Apr 17, 2019

Study contacts

Joshua Feazell, BS
Contact
JF9RF@virginia.edu
434-297-5682
Brigitte J Kelly, BSN RN CCRC
Contact
bjk3c@virginia.edu
434-297-7136
Ziv J Haskal, MD
principal investigator · Professor of Radiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Hyperplasia→

Other studies from this sponsor

University of Virginia

Start the discussion