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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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