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LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study

University of North Carolina at Chapel Hill


Description

This is a pilot study do determine the preliminary measures related to changes in prostate symptoms following a new procedure, prostatic artery embolization (PAE) to treat benign hyperplasia (BPH).


Keywords:

Men's Health


Category:

Device

Qualifications

 


Age
40 - 99 years


Gender
Male


Study Population

We will include 20 adult males subjects with benign hyperplasia (BPH) in this study. Patients will be recruited from UNC and Vascular Institute of Virginia.


Investigator

Ari Isaacson
Clinical Associate Professor
Heart and Vascular - Vascular Interventional Radiology

For questions, contact:

Terry Hartman, MPH, MS, CCRC
terry_hartman@med.unc.edu
(919) 966-4997


Recruitment Period End

December 31, 2018

Location

Primary Location
UNC Hospitals- VIR Clinic

Secondary Location
Vascular Institute of Virginia
14085 Crown Ct, Woodbridge, VA 22193, USA

Study Qualifications

Gender Male

Age Range 40 - 99 years

Participant qualification(s) 1. Male 2. Age > 40 3. Prostate gland >50 grams 4. Have previously taken BPH medication for 6 months without desired improvement or has started medication and stopped due to unwanted side effects 5. Moderate to severe lower urinary tract symptoms 6. Low peak urine flow rate 7. Capable of giving informed consent 8. Life expectancy greater than 1 year

Not eligible if: 1. Severe vascular disease 2. Uncontrolled diabetes 3. Immunosuppression 4. Abnormalities related to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. 5. Complete inability to urinate 6. Impaired kidney function unless anuric and on dialysis. 7. Confirmed or suspected bladder cancer 8. Certain symptoms of the bladder 9. Ongoing infection in the genitals 10. Previous pelvic radiation or radical pelvic surgery 11. Confirmed or suspected malignancy of the prostate 12. Uncorrectable inability of the blood to clot 13. Contrast hypersensitivity that cannot be prevented with other medications

Number of Visits

    » 5 In person visit(s)

    4 clinic visits, 1 procedure visit

    » 1 Remote visit(s)

    1 phone

Participation Period

12 months

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.