Benign Prostatic Hyperplasia (BPH)NCT01896973
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
A study testing Vortx Rx - Histotripsy BPH Device in people with Benign Prostatic Hyperplasia (BPH), run by HistoSonics, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Vortx Rx - Histotripsy BPH Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univerisity of Michigan
Ann Arbor, Michigan, 48109
ProMedica Parkway Surgery Center
Toledo, Ohio, 43606
About this study
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.
Read the detailed description
Prospective, single-arm study
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Vortx Rx - Histotripsy BPH Device
- Keywords
- Benign Prostatic Hyperplasia, BPH, LUTS, Vortx Rx, Histotripsy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortx Rx - Histotripsy BPH DeviceDevice
Also called HistoSonics Histotripsy BPH device, Vortx Rx
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.
| Study group | Role | What they receive |
|---|---|---|
| Vortx Rx - Histotripsy BPH Device | Experimental | 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. Receives: Device: Vortx Rx - Histotripsy BPH Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Vortx Rx for treatment of symptomatic BPH
- 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.
Measured: 1 Day, 1, 3 and 6 months
Secondary outcomes (1)
Initial prostate histotripsy treatment efficacy
- 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.
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Study stopped due to business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timonthy Schuster, MD, Principal investigator, ProMedica Parkway Surgery CenterJohn Wei, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896973
- Sponsor's protocol ID
- 01.CP.0.1
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2013
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)
- ClinicalTrials.gov ID
- NCT01896973
- Acronym / sponsor ID
- 01.CP.0.1
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign Prostatic Hyperplasia, BPH, LUTS, Vortx Rx, Histotripsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to business decision
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective, single-arm study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortx Rx - Histotripsy BPH Device | Experimental | Device: Vortx Rx - Histotripsy BPH DeviceThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortx Rx - Histotripsy BPH DeviceAlso: HistoSonics Histotripsy BPH device, Vortx RxNon-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. | Device | Vortx Rx - Histotripsy BPH Device |
Primary outcome
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.
1 secondary outcome
Initial prostate histotripsy treatment efficacy
Time frame: 1, 3 and 6 months
Results and safety
The study was stopped early (reason given: Study stopped due to business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timonthy Schuster, MD principal investigator
ProMedica Parkway Surgery Center
John Wei, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vortx Rx - Histotripsy BPH Device in people with Benign Prostatic Hyperplasia (BPH), run by HistoSonics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Vortx Rx for treatment of symptomatic BPH (time frame: 1 Day, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.