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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01896973
Recruitment Status : Terminated (Study stopped due to business decision)
First Posted : July 11, 2013
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
HistoSonics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: Vortx Rx - Histotripsy BPH Device Not Applicable

Detailed Description:
Prospective, single-arm study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other Names:
  • HistoSonics Histotripsy BPH device
  • Vortx Rx

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Initial prostate histotripsy treatment efficacy [ Time Frame: 1, 3 and 6 months ]
    1. 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.
    2. 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.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of BPH and eligible for endoscopic BPH surgery including TURP, PVP, electrovaporization.
  2. Prostate volumes 30 - 80 gm based on transrectal ultrasound
  3. Men ≥ 50 years of age
  4. IPSS symptom score ≥ 13 and IPSS bother score > 2 (see Appendix B for IPSS questionnaire)
  5. Baseline peak flow rate Qmax ≤ 15 cc/s with voided volume at least 125 cc

Exclusion Criteria:

  1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine > 1.4)
  2. Neurogenic bladder, Parkinson's disease
  3. Prior treatment for urinary incontinence
  4. 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?"
  5. 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
  6. Active UTI (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)
  7. PVR > 250 at time of enrollment or catheter dependent bladder drainage
  8. History of chronic prostatitis within the last 5 years
  9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment
  10. 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.
  11. Prior BPH prostate procedures (e.g. TUMT, TUNA, water induced thermotherapy [WIT], TURP, PVP)
  12. 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.
  13. Men interested in future fertility
  14. Declines or unable to provide informed consent
  15. Non-English-speaker
  16. Life expectancy estimated to be less than one year
  17. Unable or unwilling to complete all required questionnaires and follow-up assessments
  18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01896973

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United States, Michigan
Univerisity of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
ProMedica Parkway Surgery Center
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
HistoSonics, Inc.
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Principal Investigator: Timonthy Schuster, MD ProMedica Parkway Surgery Center
Principal Investigator: John Wei, MD University of Michigan
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Responsible Party: HistoSonics, Inc. Identifier: NCT01896973    
Other Study ID Numbers: 01.CP.0.1
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: February 2017
Keywords provided by HistoSonics, Inc.:
Benign Prostatic Hyperplasia
Vortx Rx
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases