Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2018-07-13
2020-09-03
Brief Summary
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Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All patients
Patients will receive the Prostatic Artery Embolization procedure.
Prostatic Artery Embolization
LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
Interventions
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Prostatic Artery Embolization
LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \> 40
3. Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA)
4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
5. Moderate to severe LUTS as defined by IPSS score \>18
6. Peak urine flow rate (Qmax) \<12 mL/sec
7. Capable of giving informed consent
8. Life expectancy greater than 1 year
Exclusion Criteria
2. Uncontrolled diabetes mellitus
3. Immunosuppression
4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
5. Complete urinary retention
6. 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.
7. Confirmed or suspected bladder cancer
8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
9. Ongoing urogenital infection
10. Previous pelvic radiation or radical pelvic surgery
11. 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).
12. Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
40 Years
MALE
No
Sponsors
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BTG International Inc.
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Ari Isaacson, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UNC Hospitals
Chapel Hill, North Carolina, United States
Vascular Institute of Virginia
Woodbridge, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-2782
Identifier Type: -
Identifier Source: org_study_id
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