Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH

Completed · Not applicable

Conditions studied: Treatment of Benign Prostatic Hyperplasia

In brief

Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure. The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.

Key facts

Study ID

NCT02683980

Run by

Boston Scientific Corporation

People needed

20

Starts

2016-02-01

Expected to finish

2017-11-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subject will be older than 18 years of age
• Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
• Subject is a candidate for surgery treatment
• Subject is willing and has signed the Informed Consent Form
• AUA score ≥ 12
• Qmax <15 mL/s

You may not qualify if…

• Need to perform concomitant procedure, other than prostate vaporization
• PVR > 300 mL
• Current Urine retention and Pdet <40 cm H20
• Documented or suspected prostate cancer and / or bladder cancer
• Neurogenic bladder disorder / neurogenic voiding dysfunction
• Urethral strictures
• Previous prostatic, bladder neck, or urethral surgery
• Known history of spinal cord injury
• Urogenital trauma
• Bladder neck stricture
• Evidence of urinary tract infection
• History of chronic prostatitis

Where it is running

• New York Methodist Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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