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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02592473
Other study ID # 18236
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date November 2021

Study information

Verified date April 2019
Source University of Virginia
Contact Joshua Feazell, BS
Phone 434-297-5682
Email JF9RF@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Virginia Health Systems Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) QMax (peak urinary flow rate) assessment 12 months
Primary Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures 2 weeks
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) QMax assessment 24 months
Primary Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures 24 months
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) IPSS (International Prostate Symptom Score) 12 months
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) IPSS 24 months
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) QoL(quality of life question) 12 months
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) QoL 24 months
Primary Clinical improvement in Lower Urinary Tract Symptoms (LUTS) QMax 24 months
Secondary Urine flow rate as measured by QMax 1 month
Secondary Urine flow rate as measured by QMax 24 months
Secondary Post-void residual measured in ml/cc 1 month
Secondary Post-void residual measured in ml/cc 24 months
Secondary UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score 1 month
Secondary UCLA-PCI-SF score 24 months
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