Recruiting

PAE

Sponsor:

University of Virginia

Code:

NCT02592473

Conditions

Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH)

Prostatism

Lower Urinary Tract Symptoms (LUTS)

Prostatic Hypertrophy

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Embozene Microspheres

Study Details

Brief 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

Study ID

NCT02592473

Start date

Nov, 2015

Status verified date

Apr, 2019

Completion date

Nov, 2021

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Embozene Microspheres

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

Primary outcome measure

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 2 weeks ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 24 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Joshua Feazell, BS

434-297-5682JF9RF@virginia.edu

Brigitte J Kelly, BSN RN CCRC

434-297-7136bjk3c@virginia.edu

Locations

University of Virginia Health Systems

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Joshua Feazell, BS

434-297-5682jf9rf@virginia.edu

Brigitte J Kelly, BSN RN CCRC

434-297-7136bjk3c@virginia.edu

Principal Investigator:

Ziv J Haskal, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 17, 2019

Last verified

Apr, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-04-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.