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A Prospective Evaluation of the GreenLight Model 120 Laser

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GreenLight Model 120 Laser System
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • New York-Presbyterian Hospital Cornell Univeristy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the effectiveness of the Laserscope GDD

Full Information

First Posted
August 11, 2006
Last Updated
January 16, 2008
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00364585
Brief Title
A Prospective Evaluation of the GreenLight Model 120 Laser
Official Title
A Prospective Evaluation of the GreenLight Model 120 Laser System for the Treatment of Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
GreenLight Model 120 Laser System
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP)
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of the Laserscope GDD

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Te, MD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York-Presbyterian Hospital Cornell Univeristy
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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A Prospective Evaluation of the GreenLight Model 120 Laser

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