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GreenLight XPS Laser System Retrospective Chart Review

NCT ID: NCT02139969

Last Updated: 2020-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

956 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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GreenLight XPS Laser System

Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber

GreenLight XPS Laser System

Intervention Type DEVICE

Interventions

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GreenLight XPS Laser System

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmood A. Hai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliates Division, Comprehensive Urology

Locations

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El Camino Urology Medical Group, Inc.

Mountain View, California, United States

Site Status

Georgia Urology

Atlanta, Georgia, United States

Site Status

Affiliates Division, Comprehensive Urology

Westland, Michigan, United States

Site Status

Houston Metro Urology

Houston, Texas, United States

Site Status

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States

Site Status

University of Montreal Hospital Center

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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PE1401

Identifier Type: -

Identifier Source: org_study_id