Benign Prostatic HyperplasiaWOLVERINENCT07214675
The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
A study testing HistoSonics Edison System in people with Benign Prostatic Hyperplasia, run by HistoSonics, Inc. at 1 site in Hong Kong.
Trial summary
The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- HistoSonics Edison System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Mar 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject is ≥ 50 years of age.
- Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
- Subject is diagnosed with BPH.
- Subject has a Body Mass Index (BMI) < 27.
- Subject has an I-PSS ≥ 15.
- Subject has a prostate volume > 30 mL and ≤ 150 mL.
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- Subject has a Qmax ≤ 15 mL/s with a voided volume of ≥ 125 mL during a uroflow test.
- Subject accepts the potential loss of ejaculatory function.
- Subject can tolerate general anesthesia. Index-Procedure Imaging Inclusion (Assessed day of procedure)
- Subject has an adequate acoustic window to visualize the prostate using the HistoSonics Edison System.
- Target treatment volume is ≥ 1 cm from the rectum as visualized on ultrasound, CT or MR imaging.
Who cannot join
- Subject has a life expectancy of less than one (1) year.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
- Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
- Subject has uncorrectable coagulopathy.
- Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤14 days prior to the planned index procedure date.
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- Subject has had a prostatectomy.
- Subject has acute prostatitis.
- Subject has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome.
- Subject has had a urinary tract infection (UTI) ≤ 3 months prior to the planned index procedure date.
- Subject has bladder stones.
- Subject is catheter dependent or has a history of intermittent self-catheterization.
- Presence of prostatic calcifications in the planned treatment volume (PTV).
- Presence of permanent radioactive implants in the rectal wall.
- Subject has has a major abdominal or rectal surgery that inhibits visualization of the prostate.
- Subject has undergone prior locoregional therapy (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
- Subject has planned locoregional therapy 6 months post index procedure (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
- Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
- Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
- In the investigator's opinion, histotripsy is not a treatment option for the subject.
- Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
- Subject's prostate is not treatable by the System's working ranges (refer to User Guide).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Becky Lau, beckylau@surgery.cuhk.edu.hk
Peter Chiu, MD
About this study
The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
Read the detailed description
This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of BPH. Following histotripsy, subjects will undergo imaging ≤ 72 hours post-index procedure. Additionally, subjects will be followed at 30-day, 90-day and 180-day timepoints.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- HistoSonics Edison System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics Edison SystemDevice
Also called Histotripsy
The HistoSonics Edison System is intended for the non-invasive mechanical destruction of prostate tissue for the treatment of BPH using histotripsy, a non-thermal, mechanical process of focused ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics Edison System | Experimental | Not described Receives: Device: HistoSonics Edison System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Index-Procedure Related Adverse Events Classified by Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE)
Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). [Clinical Events Committee Adjudicated]
Measured: 30 days post histotripsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start20 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Model description
- This is a prospective multi-center, single-arm, feasibility trial.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214675
- Sponsor's protocol ID
- CSP5895
- Acronym
- WOLVERINE
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
- ClinicalTrials.gov ID
- NCT07214675
- Acronym / sponsor ID
- WOLVERINE / CSP5895
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- 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 purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
Detailed description
This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of BPH. Following histotripsy, subjects will undergo imaging ≤ 72 hours post-index procedure. Additionally, subjects will be followed at 30-day, 90-day and 180-day timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective multi-center, single-arm, feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| HistoSonics Edison System | Experimental | Device: HistoSonics Edison System |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is ≥ 50 years of age.
- Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
- Subject is diagnosed with BPH.
- Subject has a Body Mass Index (BMI) < 27.
- Subject has an I-PSS ≥ 15.
Key exclusion criteria (22 listed)
- Subject has a life expectancy of less than one (1) year.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
- Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
- Subject has uncorrectable coagulopathy.
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 |
|---|---|---|
| HistoSonics Edison SystemAlso: HistotripsyThe HistoSonics Edison System is intended for the non-invasive mechanical destruction of prostate tissue for the treatment of BPH using histotripsy, a non-thermal, mechanical process of focused ultrasound. | Device | HistoSonics Edison System |
Primary outcome
Number of Index-Procedure Related Adverse Events Classified by Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 30 days post histotripsy procedure
Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). [Clinical Events Committee Adjudicated]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics Edison System in people with Benign Prostatic Hyperplasia, run by HistoSonics, Inc. at 1 site in Hong Kong.
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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Erickson (612-965-8895, Kelly.Erickson@histosonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Index-Procedure Related Adverse Events Classified by Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE) (time frame: 30 days post histotripsy procedure). 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 9 Apr 2026.