A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization

Completed · Phase 4

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT00465101

Run by

American Medical Systems

People needed

150

Starts

2007-05-01

Expected to finish

2013-01-01

Last updated by the study team

2015-10-28

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA — Los Angeles, California, United States
• Connecticut Clinical Reseach Center — Middlebury, Connecticut, United States
• North Fulton Urology, P.C. — Roswell, Georgia, United States
• Affiliates in Urology — Detroit, Michigan, United States
• PC Group/Universtiy Urology Association — New York, New York, United States
• Glickman Urological Institute — Cleveland, Ohio, United States
• Oklahoma University Health Science Center_Urology — Oklahoma City, Oklahoma, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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