A Prospective Evaluation of the GreenLight Model 120 Laser

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Prospective Evaluation of the GreenLight Model 120 Laser System for the Treatment of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364585
• Other study ID #: 0604008494
• Secondary ID: 0000022806
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2006
• Last updated: January 16, 2008
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• GreenLight Model 120 Laser System

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital Cornell Univeristy	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP)
Secondary	To evaluate the effectiveness of the Laserscope GDD