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



Status:Active, not recruiting
Conditions:Hematology, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:8/30/2017
Start Date:February 2016
End Date:September 2017

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Trial Summary
Trial Overview
Inclusion Criteria
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 PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with
recommended settings.


Inclusion Criteria:

- 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

Exclusion Criteria:

- Need to perform concomitant procedure, other than prostate vaporization

- PVR > 300mL

- 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
We found this trial at
1
site
New York Methodist Hospital
New York, New York 11215
?
mi
from
New York, NY
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