- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736512
China Greenlight Registry Study (Post-market)
November 13, 2023 updated by: Boston Scientific Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
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
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hosptital, Sun Yat-sen University
-
-
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
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Men diagnosed with benign prostatic hyperplasia (BPH) for whom GreenLight Laser therapy is recommended by their physician and eligible for inclusion.
Description
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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)
- 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
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6-month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jian Huang, Doctor, Sun Yat-sen Memorial Hosptital, Sun Yat-sen 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 (Actual)
February 27, 2019
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
November 29, 2021
Study Registration Dates
First Submitted
September 4, 2017
First Submitted That Met QC Criteria
November 7, 2018
First Posted (Actual)
November 9, 2018
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U0597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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.
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