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

Study Overview
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Brief Summary
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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
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Prospective, single-arm study

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

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: Vortx Rx - Histotripsy BPH Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of BPH and eligible for endoscopic BPH surgery including TURP, PVP, electrovaporization. Prostate volumes 30 - 80 gm based on transrectal ultrasound Men ≥ 50 years of age IPSS symptom score ≥ 13 and IPSS bother score > 2 (see Appendix B for IPSS questionnaire) Baseline peak flow rate Qmax ≤ 15 cc/s with voided volume at least 125 cc Exclusion Criteria: History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine > 1.4) Neurogenic bladder, Parkinson's disease Prior treatment for urinary incontinence Micturition frequency AND urgency. Micturition frequency defined as > 8 micturitions per 24 hours as assessed by a thorough subject history including the question: On average, how many times do you void during a 24 hour period? // < 4, 5-7, 8 or more. Urgency defined as an uncontrollable urge to void that occurs > 3 per 24 hours as assessed through the subject history/question: On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more? Intravesical prostate lobe protrusion > 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe Active UTI (i.e. must have a screening urinalysis without signs of infection or a negative urine culture) PVR > 250 at time of enrollment or catheter dependent bladder drainage History of chronic prostatitis within the last 5 years Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment History of known bleeding disorders (e.g. von Willebrand disease [VWD]) and subjects determined to have a bleeding disorder by prothrombin time (PT) and partial thromboplastin time (PTT) tests. Prior BPH prostate procedures (e.g. TUMT, TUNA, water induced thermotherapy [WIT], TURP, PVP) Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA > 10 ng/mL. Men with free PSA < 25% and PSA between 2.5 and 10 ng/mL may only be enrolled after a negative biopsy. If a prior prostate biopsy was performed within one year of enrollment and was negative for cancer, repeat biopsy is not required if in the investigator's judgment there is no clinical evidence to support biopsy reassessment. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is otherwise deemed eligible to participate in the study. Men interested in future fertility Declines or unable to provide informed consent Non-English-speaker Life expectancy estimated to be less than one year Unable or unwilling to complete all required questionnaires and follow-up assessments In the opinion of the investigator, it is not in the subject's best interest to participate in the study.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortx Rx - Histotripsy BPH Device<br>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<br>* 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.<br>* Other names: Vortx Rx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Vortx Rx for treatment of symptomatic BPH | 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. | 1 Day, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial prostate histotripsy treatment efficacy | 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. | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Benign Prostatic Hyperplasia, LUTS, Vortx Rx, Histotripsy