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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01775488
• Other study ID #: 01.CP.0.2
• Status: Withdrawn
• Phase: N/A
• First received: January 21, 2013
• Last updated: August 17, 2015
• Start date: June 2013

Study information

• Verified date: August 2015
• Source: HistoSonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of BPH and eligible for endoscopic BPH surgery including Transurethral Resection of the Prostate [TURP], PVP, electrovaporization

2. Prostate volumes 30 - 80 gm based on transrectal ultrasound

3. Men = 50 years of age

4. IPSS symptom score > 15 and IPSS bother score > 2

5. Baseline peak flow rate Qmax < 12 cc/s on two separate occasions with voided volume at least 150 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 Urinary Tract Infection [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)

11. Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy [TUMT], TUNA, water induced thermotherapy, 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 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.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Vortx Rx - Histotripsy BPH 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HistoSonics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Up to six months	No