NCT01896973

Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prospective, single-arm study

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-07-11
• Last updated: 2023-11-07

Locations

2 sites across 1 country: United States