Benign Prostatic Hyperplasia (BPH)NCT03736512
China Greenlight Registry Study (Post-market)
An observational study of Benign Prostatic Hyperplasia (BPH), run by Boston Scientific Corporation at 1 site in China.
Trial summary
The duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow-up visits. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2019to 29 Nov 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Men diagnosed with benign prostatic hyperplasia (BPH) for whom GreenLight Laser therapy is recommended by their physician and eligible for inclusion.
Who may be able to join
- Subject has provided informed consent and agrees to attend all study visits
- Subject has a diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
- Subject is able to complete self-administered questionnaires
- Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for the PVP procedure
- Subject is ≥ 40 years of age
- Subject has an IPSS score greater than or equal to 12 measured at the baseline visit
- Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than or equal to 15ml/s and sample is greater than or equal to 150ml (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 150ml, and the Qmax is less than or equal to 15ml/s it may be used for the inclusion/exclusion criteria)
- Subject has medical record documentation of a prostate volume of greater than or equal to 30 grams by transrectal ultrasound (TRUS))
Who cannot join
- Subject has a life expectancy of less than 2 years
- Subject is classified as American Society of Anesthesiologists (ASA) V
- Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
- Subject has an active infection that would preclude operation within 14 days of the study procedure (e.g., urinary tract infection or prostatitis)
- Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (e.g., non-bacterial chronic prostatitis)
- Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries)
Show all 16Show fewer
- Subject has a diagnosis of polyneuropathy (e.g., diabetic)
- Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
- Subject has a diagnosis of prostate cancer or suspected prostate cancer based on PSA results and meeting the following:
- PSA level of 4 - 10 with an abnormal DRE (if biopsy collected must be positive); PSA level greater than 10 with a positive biopsy
- Subject has a history of CIS, TaGIII or any T1 stage bladder cancer
- Subject has damage to external urinary sphincter
- Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent
- Subject is immunocompromised (e.g., organ transplant, leukemia)
- Subject currently or has a history of upper urinary tract stones
- Subject currently diagnosed with OAB and treated with medication If the subject does not carry a diagnosis but is suspected to have OAB, the investigator must use his/her discretion
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hosptital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Prospective Registry of Outcomes With the GreenLight™ Laser System
The duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow-up visits.
Read the detailed description
The study follow-up duration from the primary study procedure is 5 years.
- Baseline
- Study Procedure
- 4-week
- 6-month
- 12-month
- 24-month (End of Study) The study will be considered complete after all subjects have completed the 24-month follow-up visit.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber
- 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 XPS™ 532 nm Laser System with MoXy™ laser fiberDevice
observational registry
What is being measured
The primary outcome is the main question the study is designed to answer.
The GreenLight XPS system provides durable relief of BPH symptoms in subjects.
Changes of IPSS Scores in subjects treated with the GreenLight XPS Laser System at 6 months
Measured: 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start27 Feb 2019
- Primary completion30 Mar 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Huang, Doctor, Principal investigator, Sun Yat-sen Memorial Hosptital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736512
- Sponsor's protocol ID
- U0597
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2017
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Outcomes With the GreenLight™ Laser System
- ClinicalTrials.gov ID
- NCT03736512
- Acronym / sponsor ID
- U0597
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- 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 duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow-up visits.
Detailed description
The study follow-up duration from the primary study procedure is 5 years.
- Baseline
- Study Procedure
- 4-week
- 6-month
- 12-month
- 24-month (End of Study) The study will be considered complete after all subjects have completed the 24-month follow-up visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men diagnosed with benign prostatic hyperplasia (BPH) for whom GreenLight Laser therapy is recommended by their physician and eligible for inclusion.
Key inclusion criteria (8 listed)
- Subject has provided informed consent and agrees to attend all study visits
- Subject has a diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
- Subject is able to complete self-administered questionnaires
- Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for the PVP procedure
- Subject is ≥ 40 years of age
Key exclusion criteria (16 listed)
- Subject has a life expectancy of less than 2 years
- Subject is classified as American Society of Anesthesiologists (ASA) V
- Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
- Subject has an active infection that would preclude operation within 14 days of the study procedure (e.g., urinary tract infection or prostatitis)
- Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (e.g., non-bacterial chronic prostatitis)
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 XPS™ 532 nm Laser System with MoXy™ laser fiberobservational registry | Device | – |
Primary outcome
The GreenLight XPS system provides durable relief of BPH symptoms in subjects.
Time frame: 6-month follow up
Changes of IPSS Scores in subjects treated with the GreenLight XPS Laser System at 6 months
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 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Benign Prostatic Hyperplasia (BPH)
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
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.
Jian Huang, Doctor principal investigator
Sun Yat-sen Memorial Hosptital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by Boston Scientific Corporation at 1 site in China.
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 8 inclusion and 16 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 15 Nov 2023. 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 China. 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.
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?
The GreenLight XPS system provides durable relief of BPH symptoms in subjects. (time frame: 6-month follow up). 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 15 Nov 2023.