Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy device. The purpose of this study is to assess and monitor the performance of the Vortx Rx for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)|
- Safety of the Vortx Rx for treatment of symptomatic BPH [ Time Frame: 1 Day, 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
- Record and report all adverse events.
- Determine rate of occurrence of adverse events, serious adverse events and device-related adverse events as a measure of safety and as factors used to determine study success.
- Initial prostate histotripsy treatment efficacy [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
- Change in LUTS as measured by International Prostate Symptom Score (IPSS), uroflow (Qmax), post-void residual (PVR). Each to be measured at 1, 3 and 6 months.
- Change in prostate parenchymal volume (TRUS and prostate-specific antigen [PSA]). TRUS to be performed at end of treatment and at 6 months post-treatment. PSA to be tested 6 months post-treatment.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (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 the surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the end of 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.
Prospective, single-arm study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896973
|Contact: Timothy Schuster, MDemail@example.com|
|Contact: Tiffanie Barnhizer, RNfirstname.lastname@example.org|
|United States, Michigan|
|Univerisity of Michigan||Active, not recruiting|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|ProMedica Parkway Surgery Center||Recruiting|
|Toledo, Ohio, United States, 43606|
|Contact: Timothy Schuster, MD 419-531-8349 email@example.com|
|Contact: Tiffanie Barnhizer, RN 419-291-7820 firstname.lastname@example.org|
|Principal Investigator: Timothy Schuster, MD|
|Principal Investigator:||Timonthy Schuster, MD||ProMedica Parkway Surgery Center|
|Principal Investigator:||John Wei, MD||University of Michigan|