|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)|
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Vortx Rx - Histotripsy BPH Device
The Vortx Rx, is a portable ultrasound therapy device system that is intended for the treatment of BPH by using very intense, low duty-cycle ultrasound pulses to debulk prostatic tissue.
Device: Vortx Rx - Histotripsy BPH Device
Non-invasive histotripsy treatment / therapy to be delivered by surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.
Other Name: HistoSonics Histotripsy BPH Device