GreenLight XPS Laser System Retrospective Chart Review

October 16, 2020 updated by: Boston Scientific Corporation

GreenLight XPS Laser System for the Treatment of Benign Prostatic Hyperplasia: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review

The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.

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

This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.

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.
956

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • University of Montreal Hospital Center
  • United States
    • California
      • Mountain View, California, United States, 94040
        • El Camino Urology Medical Group, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Georgia Urology
    • Michigan
      • Westland, Michigan, United States, 48186
        • Affiliates Division, Comprehensive Urology
    • Texas
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia, PLLC

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of males who have had the GreenLight XPS procedure with the MoXy fiber on or after 01-Aug-2010. The cohort will be selected from six pre-selected urology clinics in the US and one pre-selected urology clinic in Canada.

Description

Inclusion Criteria:

  • Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.

Exclusion Criteria:

  • Subject has had prior radiation.
  • Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))
  • Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)
  • Subject has an artificial urinary sphincter

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
GreenLight XPS Laser System
Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber
Device: GreenLight XPS Laser System

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
International Prostate Symptom Score (IPSS)
Time Frame: 6 months post-procedure
Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of >21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.
6 months post-procedure
Occurrence of Adverse Events Related to the Study Treatment.
Time Frame: 365 Days

Treatment-related adverse events include:

  • Event related to the study device or procedure
  • Intra-operative adverse event related to the study device or procedure
  • Serious adverse events related to the study device or procedure

The number of events as well as the number and percentage of subjects with the event will be calculated.
365 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characteristics of the Study Procedure
Time Frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Summary of the study procedure, including length of procedure and lasing time
Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Characteristics of the Study Procedure and Immediate Outcomes
Time Frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)
Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Assess Changes in Quality of Life Related to BPH Symptoms.
Time Frame: Baseline through six months post-procedure
Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome.
Baseline through six months post-procedure
Assess Changes in Objective Measures of Urologic Function.
Time Frame: Baseline through six months post-procedure.
Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)
Baseline through six months post-procedure.
Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure
Time Frame: Up to 90 days post-procedure.
  • Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure
  • Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure
  • Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure
Up to 90 days post-procedure.
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence
Time Frame: 90 days, 180 days
The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point.
90 days, 180 days
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.
Time Frame: Procedure through five years post-procedure.
Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.
Procedure through five years post-procedure.
Characteristics of the Study Procedure and Immediate Outcomes
Time Frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Summarize characteristics of the study procedure and immediate outcomes: length of catheterization
Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Length of Hospital Stay
Time Frame: The number of days from admission through discharge from the medical facility will be measured.
Summarize length of hospital stay (in days) from admission through discharge
The number of days from admission through discharge from the medical facility will be measured.
Type of Hospital Stay
Time Frame: Data will be collected during the time of their hospital stay from admission through discharge
Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)
Data will be collected during the time of their hospital stay from admission through discharge
Number of Participants Stratified by Number of Fibers Used During Procedure
Time Frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Summarize characteristics of the study procedure and immediate outcomes: number of fibers used
Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Assess Changes in Objective Measures of Urologic Function
Time Frame: Baseline through six months post-procedure
Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual
Baseline through six months post-procedure
Changes in Objective Measures of Urologic Function
Time Frame: Baseline through six months post-procedure.
Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume
Baseline through six months post-procedure.
Assess Changes in Objective Measures of Urologic Function.
Time Frame: From baseline through six months post-procedure.
Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen
From baseline through six months post-procedure.

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: Mahmood A. Hai, M.D., Affiliates Division, Comprehensive Urology

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

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.
May 1, 2014

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.
November 1, 2014

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 1, 2014

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).
May 13, 2014

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.
May 14, 2014

First Posted (Estimate)

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.
May 16, 2014

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 9, 2020

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.
October 16, 2020

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.
January 1, 2018

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.
  • PE1401

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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