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Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

NCT01500057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-05-14

Study results available
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Summary

This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

Greenlight XPS Laser

Treatment of BPH with Greenlight XPS laser

DEVICE

BiVAP Saline Vaporization of the prostate

treatment of BPH with BiVAP Saline Vaporization

Sponsors & Collaborators

  • American Medical Systems

    collaborator INDUSTRY

  • Richard Wolf Medical Instruments Corporation (RWMIC)

    collaborator UNKNOWN

  • Brooklyn Urology Research Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-10-10
Completion
2016-10-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500057 on ClinicalTrials.gov