- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00364585
A Prospective Evaluation of the GreenLight Model 120 Laser
January 16, 2008 updated by: Weill Medical College of Cornell University
A Prospective Evaluation of the GreenLight Model 120 Laser System for the Treatment of Benign Prostatic Hyperplasia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- New York-Presbyterian Hospital Cornell Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP)
|
Secondary Outcome Measures
Outcome Measure |
---|
To evaluate the effectiveness of the Laserscope GDD
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexis Te, MD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 14, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
January 17, 2008
Last Update Submitted That Met QC Criteria
January 16, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0604008494
- 0000022806
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia
-
St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
San Carlo di Nancy HospitalElesta S.R.L.CompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy | Benign Prostatic Hypertrophy With Outflow Obstruction | Prostate HyperplasiaItaly
-
GlaxoSmithKlineCompletedBenign Prostatic Hyperplasia
-
Catholic University of the Sacred HeartCompletedBenign Prostatic Hyperplasia (BPH) | Benign Prostatic Enlargement (BPE)Italy
-
Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
-
Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
-
IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
-
IRCCS Policlinico S. MatteoCompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy With Outflow ObstructionItaly
-
American Medical SystemsCompletedBenign Prostatic Hyperplasia | BPH | Benign Prostatic Hypertrophy | Prostate Disease
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Not yet recruitingLower Urinary Tract Symptoms | Benign Prostate Hyperplasia | Benign Prostatic Hypertrophy With Outflow Obstruction
Clinical Trials on GreenLight Model 120 Laser System
-
Boston Scientific CorporationCompletedBenign Prostatic HyperplasiaUnited States, Canada
-
Mansoura UniversityCompletedBenign Prostatic HyperplasiaEgypt
-
Mansoura UniversityUnknownBenign Prostatic HyperplasiaEgypt
-
Boston Scientific CorporationCompleted
-
Brooklyn Urology Research GroupAmerican Medical Systems; Richard Wolf Medical Instruments Corporation (RWMIC)CompletedBenign Prostatic Hyperplasia (BPH)United States
-
St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
Alcon ResearchRecruitingRefractive ErrorsAustralia
-
Cedar, United KingdomNational Institute for Health and Care Excellence (NICE); British Society of... and other collaboratorsUnknownTransurethral Resection of the Prostate (TURP) | Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE) | Prostate Artery Embolisation (PAE) | Open Prostatectomy | Laser Enucleation or Ablation of the Prostate
-
Alcon ResearchCompletedRefractive Error - Myopia Severe | Refractive Error - Myopia SimpleUnited States, Ireland, Singapore
-
Bausch & Lomb IncorporatedRecruiting