Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
|ClinicalTrials.gov Identifier: NCT01896973|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2013
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH)||Device: Vortx Rx - Histotripsy BPH Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2020|
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.
- Safety of the Vortx Rx for treatment of symptomatic BPH [ Time Frame: 1 Day, 1, 3 and 6 months ]
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896973
|United States, Michigan|
|Univerisity of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|ProMedica Parkway Surgery Center|
|Toledo, Ohio, United States, 43606|
|Principal Investigator:||Timonthy Schuster, MD||ProMedica Parkway Surgery Center|
|Principal Investigator:||John Wei, MD||University of Michigan|