A Prospective Evaluation of the GreenLight Model 120 Laser

NCT00364585 | Completed Phase 4

• 2 other identifiers: 06040084940000022806
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

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

Interventions

GreenLight Model 120 Laser System DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who refuse to sign the Informed Consent document and/or comply with all follow-up requirements.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York-Presbyterian Hospital Cornell Univeristy

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexis Te, MD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2006
• Study Completion: April 1, 2007
• Last Updated: January 17, 2008

Record last verified: 2008-01

Locations

US (1)