Status:
COMPLETED
LC Bead LUMI for Prostatic Artery Embolization
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
BTG International Inc.
Conditions:
BPH
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPS...
Detailed Description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in pros...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male
- Age \> 40
- Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA)
- Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
- Moderate to severe LUTS as defined by IPSS score \>18
- Peak urine flow rate (Qmax) \<12 mL/sec
- Capable of giving informed consent
- Life expectancy greater than 1 year
- Exclusion Criteria
- Severe vascular disease
- Uncontrolled diabetes mellitus
- Immunosuppression
- Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- Complete urinary retention
- Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- Confirmed or suspected bladder cancer
- Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- Ongoing urogenital infection
- Previous pelvic radiation or radical pelvic surgery
- Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy).
- Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
- Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Exclusion
Key Trial Info
Start Date :
July 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03372096
Start Date
July 13 2018
End Date
September 3 2020
Last Update
February 24 2021
Active Locations (2)
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1
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
2
Vascular Institute of Virginia
Woodbridge, Virginia, United States, 22193