Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
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|ClinicalTrials.gov Identifier: NCT01896973|
Recruitment Status : Terminated (Study stopped due to business decision)
First Posted : July 11, 2013
Last Update Posted : June 8, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH)||Device: Vortx Rx - Histotripsy BPH Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 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|
|Actual Study Completion Date :||May 2018|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||HistoSonics, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 11, 2013 Key Record Dates|
|Last Update Posted:||June 8, 2018|
|Last Verified:||February 2017|
Benign Prostatic Hyperplasia
Genital Diseases, Male
Male Urogenital Diseases