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CompletedNCT00364585Updated Jan 17, 2008

A Prospective Evaluation of the GreenLight Model 120 Laser

A Phase 4 interventional study of GreenLight Model 120 Laser System in Benign Prostatic Hyperplasia, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-17.

Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
40 Years and older
Sex
Male
01

Study 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 the same power density to tissue as that of the current GreenLight model. In addition this study will examine the Laserscope GDD (guided delivery device) that has been designed exclusively for use with the GreenLight™ model 120.

Read the 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 urination, constant feeling of urgency to go to the bathroom, and difficulty passing urine due to the obstruction caused by the enlarged gland. The incidence (number of new cases) of BPH increases from 40% among males between the ages of 50 and 60 years to 90% among males older than 80 years of age. Treatment of BPH is currently undergoing intense scrutiny due to the cost and morbidity (complications and disability due to the procedure) associated with the "gold standard" treatment, Transurethral Resection of the Prostate (TURP). The TURP procedure has established its place as a standard of care for BPH due to its exceptional clinical efficacy and established long-term durability. Despite the clinical prowess of TURP, there remain significant concerns regarding the relatively high incidence of postoperative morbidity and the significant economic burden on world healthcare systems. Laser vaporization prostatectomy, on the other hand, has developed into a relatively new technological advance that has been utilized with favorable outcomes for more than a decade.

02

Conditions studied

  • Benign Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 20 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects must be male and over the age of 40 years.
  2. Subjects must present with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention, diagnosed using standard clinical practices (uroflowmetry).
  3. Subjects must present with LUTS secondary to BPH > 3 months in duration.
  4. IPPS symptom score value of > 12.
  5. Prostate size, as measured by transrectal ultrasonography, between 15 and 300 cc.
  6. Subjects that are in retention may be enrolled in the study provided that it is documented the primary cause of the retention is BPH.
  7. ASA classification of physical status, class 1-3.
  8. Subjects must read, understand, and sign the Informed Consent.
  9. Subjects must be willing and able to comply with all follow-up requirements.

Exclusion criteria

Exclusion Criteria:

  1. Unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods.
  2. Subjects with a recent myocardial infarction or coronary artery stent placement.
  3. Subjects with systemic diseases that cause significant neurogenic lower urinary dysfunction.
  4. Subjects who have had major pelvic fractures that involved damage to the external urinary sphincter.
  5. Subjects who have recently completed definitive radiation therapy for prostate cancer.
  6. Subjects with prostate cancer who are considering brachytherapy (radioactive seed implantation) or cryotherapy as part of their definitive treatment.
  7. Subjects must not have active localized or systemic infections; including active urinary tract infection.
  8. Subjects with confirmed atonic bladders and/or neurogenic bladders, reflex dyssynergia, detrusor hyporeflexia/areflexia.
  9. Subjects diagnosed with active urethral strictures, bladder neck contracture, acute prostatitis affecting bladder function.
  10. Serum prostate specific antigen level > 4 ng/ml, requiring prostate needle biopsy, and resultant positive pathology for malignancy of the prostate.
  11. Subjects with confirmed or suspected malignancy of the prostate or bladder.
  12. Subjects with renal ectasia by renal ultrasound.
  13. Immunocompromised subjects and deemed unfit for laser vaporization as determined by the attending physician.
  14. Any disorder or conditions of the subject that the investigator believes will contraindicate their inclusion in the study.
  15. Subjects who refuse to sign the Informed Consent document and/or comply with all follow-up requirements.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • DeviceGreenLight Model 120 Laser System
06

What researchers measure

Primary outcomes

  1. To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP)

Secondary outcomes

  1. To evaluate the effectiveness of the Laserscope GDD

07

Study locations

1 site
  • New York-Presbyterian Hospital Cornell Univeristy
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00364585
Lead sponsor
Weill Medical College of Cornell University
First posted
Aug 15, 2006
Start date
May 2006
Completion
Apr 2007
Last update
Jan 17, 2008

Study contacts

Alexis Te, MD
principal investigator · Cornell University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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