Status:
COMPLETED
A Prospective Evaluation of the GreenLight Model 120 Laser
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the performance of the GreenLight™ model 120 delivering higher average power to allow for more flexibility in the working distance of the delivery device with ...
Detailed Description
Benign Prostatic Hyperplasia (BPH) refers to a medical condition which occurs in aging men where the prostate gland is enlarged preventing the free flow of urine. This causes symptoms of frequent urin...
Eligibility Criteria
Inclusion
- Subjects must be male and over the age of 40 years.
- Subjects must present with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention, diagnosed using standard clinical practices (uroflowmetry).
- Subjects must present with LUTS secondary to BPH \> 3 months in duration.
- IPPS symptom score value of \> 12.
- Prostate size, as measured by transrectal ultrasonography, between 15 and 300 cc.
- Subjects that are in retention may be enrolled in the study provided that it is documented the primary cause of the retention is BPH.
- ASA classification of physical status, class 1-3.
- Subjects must read, understand, and sign the Informed Consent.
- Subjects must be willing and able to comply with all follow-up requirements.
Exclusion
- Unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods.
- Subjects with a recent myocardial infarction or coronary artery stent placement.
- Subjects with systemic diseases that cause significant neurogenic lower urinary dysfunction.
- Subjects who have had major pelvic fractures that involved damage to the external urinary sphincter.
- Subjects who have recently completed definitive radiation therapy for prostate cancer.
- Subjects with prostate cancer who are considering brachytherapy (radioactive seed implantation) or cryotherapy as part of their definitive treatment.
- Subjects must not have active localized or systemic infections; including active urinary tract infection.
- Subjects with confirmed atonic bladders and/or neurogenic bladders, reflex dyssynergia, detrusor hyporeflexia/areflexia.
- Subjects diagnosed with active urethral strictures, bladder neck contracture, acute prostatitis affecting bladder function.
- Serum prostate specific antigen level \> 4 ng/ml, requiring prostate needle biopsy, and resultant positive pathology for malignancy of the prostate.
- Subjects with confirmed or suspected malignancy of the prostate or bladder.
- Subjects with renal ectasia by renal ultrasound.
- Immunocompromised subjects and deemed unfit for laser vaporization as determined by the attending physician.
- Any disorder or conditions of the subject that the investigator believes will contraindicate their inclusion in the study.
- Subjects who refuse to sign the Informed Consent document and/or comply with all follow-up requirements.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00364585
Start Date
May 1 2006
End Date
April 1 2007
Last Update
January 17 2008
Active Locations (1)
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1
New York-Presbyterian Hospital Cornell Univeristy
New York, New York, United States, 10021