Back to resultsSafety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
Primary Purpose
Benign Prostatic Hyperplasia (BPH)
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vortx Rx - Histotripsy BPH Device
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign Prostatic Hyperplasia, BPH, LUTS, Vortx Rx, Histotripsy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vortx Rx - Histotripsy BPH Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01775488
Brief Title
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
Official Title
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Poor enrollment
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HistoSonics, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
Benign Prostatic Hyperplasia, BPH, LUTS, Vortx Rx, Histotripsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortx Rx - Histotripsy BPH Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vortx Rx - Histotripsy BPH Device
Other Intervention Name(s)
HistoSonics Histotripsy BPH Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Assess initial prostate histotripsy treatment efficacy
Description
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.
Time Frame
Up to six months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
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