Safety and Initial Efficacy Study of the Vortx Rx for Tre... | NCT01775488

NCT01775488

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vortx Rx - Histotripsy BPH Device	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vortx Rx - Histotripsy BPH Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events	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.	Up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Assess initial prostate histotripsy treatment efficacy	Change in Lower Urinary Tract Symptoms [LUTS], International Prostate Symptom Score [IPSS], uroflow (Qmax), post-void residual (PVR). Each to be measured at 1, 3 and 6 months post-treatment Change in prostate parenchymal volume including TRUS and Prostate-Specific Antigen [PSA]. TRUS to be performed at end of treatment and at 6 months post-treatment. PSA to be tested at 6 months post-treatment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of BPH and eligible for endoscopic BPH surgery including Transurethral Resection of the Prostate [TURP], PVP, electrovaporization
Prostate volumes 30 - 80 gm based on transrectal ultrasound
Men ≥ 50 years of age
IPSS symptom score > 15 and IPSS bother score > 2
Baseline peak flow rate Qmax < 12 cc/s on two separate occasions with voided volume at least 150 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 Urinary Tract Infection [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)
Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy [TUMT], TUNA, water induced thermotherapy, 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 with PSA within an age and race-specific range may only be enrolled after a negative biopsy. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is 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.

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases