A Prospective Evaluation of the GreenLight Model 120 Laser

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00364585
First received: August 11, 2006
Last updated: January 16, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: GreenLight Model 120 Laser System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of the GreenLight Model 120 Laser System for the Treatment of Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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

Estimated Enrollment: 20
Study Start Date: May 2006
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364585

Locations
United States, New York
New York-Presbyterian Hospital Cornell Univeristy
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Alexis Te, MD Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364585     History of Changes
Other Study ID Numbers: 0604008494, 0000022806
Study First Received: August 11, 2006
Last Updated: January 16, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014