Status:
COMPLETED
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Lead Sponsor:
American Medical Systems
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE4
Brief Summary
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Detailed Description
Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very of...
Eligibility Criteria
Inclusion
- All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score \>14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study
Exclusion
- American Society of Anesthesiologists (ASA) classification of physical status \> III
- An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods
- A myocardial infarction or coronary artery stent placement within 6 months of the treatment
- Neurogenic lower urinary dysfunction
- A post-void residual (PVR) volume ≥ 400 mL
- Pre-existing urinary incontinence
- Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function
- Pre-existing damage of external urinary sphincter
- Presence of cystolithiasis, urethral stricture, or bladder neck contracture
- Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
- Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated
- Immunocompromised subjects
- Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease
- Desire to preserve antegrade ejaculation
- Calcification of prostate tissue, usually after severe prostatitis
- Deemed unfit for laser vaporization as determined by the attending physician
- Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00465101
Start Date
May 1 2007
End Date
January 1 2013
Last Update
October 28 2015
Active Locations (9)
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1
UCLA
Los Angeles, California, United States, 90095
2
Connecticut Clinical Reseach Center
Middlebury, Connecticut, United States, 06762
3
North Fulton Urology, P.C.
Roswell, Georgia, United States, 30076
4
Affiliates in Urology
Detroit, Michigan, United States, 48186