- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775488
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
August 17, 2015 updated by: HistoSonics, Inc.
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: Up to 6 months
|
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess initial prostate histotripsy treatment efficacy
Time Frame: Up to six months
|
|
Up to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ANTICIPATED)
June 1, 2014
Study Registration Dates
First Submitted
January 21, 2013
First Submitted That Met QC Criteria
January 24, 2013
First Posted (ESTIMATE)
January 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 17, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01.CP.0.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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