Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Brooklyn Urology Research Group
Sponsor:
Collaborators:
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
Information provided by (Responsible Party):
Ivan Grunberger, MD, Brooklyn Urology Research Group
ClinicalTrials.gov Identifier:
NCT01500057
First received: December 16, 2011
Last updated: January 26, 2015
Last verified: January 2015

December 16, 2011
January 26, 2015
December 2011
February 2015   (final data collection date for primary outcome measure)
AUA Symptom score [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01500057 on ClinicalTrials.gov Archive Site
uroflow and post void residual [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia (BPH)
  • 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
  • Active Comparator: Greenlight XPS Laser
    Greenlight XPS Laser of the prostate
    Intervention: Device: Greenlight XPS Laser
  • Active Comparator: BiVAP Saline Vaporization
    BiVAP Saline Vaporization of the prostate
    Intervention: Device: BiVAP Saline Vaporization of the prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2016
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male over the age of 18 years
  • present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
  • subjects must read, understand and sign the Informed Consent
  • AUA ≥ 15
  • Qmax < 15mL/sec
  • Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
  • Prostate volume ≥ 30g

Exclusion Criteria:

  • PVR > 300ml
  • Current urine retention
  • Previous surgical or invasive treatments (TURP, TUMT, TUNA)
  • PSA ≥ 4 (must have negative biopsy within last 12 months)
  • Neurogenic bladder
  • Obstruction due to urethral stricture
  • Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study
Male
18 Years and older
Yes
United States
 
NCT01500057
WIRB Protocol# 20111638
No
Ivan Grunberger, MD, Brooklyn Urology Research Group
Brooklyn Urology Research Group
  • American Medical Systems
  • Richard Wolf Medical Instruments Corporation (RWMIC)
Not Provided
Brooklyn Urology Research Group
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP