Benign Prostatic HyperplasiaPhase 4NCT00364585
A Prospective Evaluation of the GreenLight Model 120 Laser
A Phase 4 study testing GreenLight Model 120 Laser System in people with Benign Prostatic Hyperplasia, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- GreenLight Model 120 Laser System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York-Presbyterian Hospital Cornell Univeristy
New York, New York, 10021
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- GreenLight Model 120 Laser System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GreenLight Model 120 Laser SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMay 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Alexis Te, MD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364585
- Sponsor's protocol ID
- 0604008494
- Other IDs
- 0000022806
- Status last verified
- Jan 2008
- First submitted
- 11 Aug 2006
- Last updated
- 17 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the GreenLight Model 120 Laser System for the Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00364585
- Acronym / sponsor ID
- 0604008494
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GreenLight Model 120 Laser System | Device | – |
Primary outcome
To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP)
1 secondary outcome
To evaluate the effectiveness of the Laserscope GDD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Te, MD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GreenLight Model 120 Laser System in people with Benign Prostatic Hyperplasia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2008.