Actively Recruiting
The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
Led by HistoSonics, Inc. · Updated on 2026-04-09
80
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
CONDITIONS
Official Title
The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 50 years of age or older.
- Subject has signed the approved informed consent form and agrees to follow trial procedures and assessments.
- Subject is diagnosed with benign prostatic hyperplasia (BPH).
- Subject has a body mass index (BMI) less than 27.
- Subject has an International Prostate Symptom Score (I-PSS) of 15 or higher.
- Subject has a prostate volume greater than 30 mL and less than or equal to 150 mL.
- Subject has a maximum urine flow rate (Qmax) of 15 mL/s or less with a voided volume of 125 mL or more during uroflow test.
- Subject accepts the potential loss of ejaculatory function.
- Subject can tolerate general anesthesia.
- Subject has an adequate acoustic window to visualize the prostate with the HistoSonics Edison System on the day of the procedure.
- Target treatment volume is at least 1 cm away from the rectum based on imaging (ultrasound, CT, or MRI).
You will not qualify if you...
- Subject has a life expectancy less than one year.
- Subject has a known allergy to contrast media and cannot be pre-medicated.
- Subject has post-void residual urine volume of 150 mL or more confirmed by ultrasound.
- Subject has an estimated glomerular filtration rate (eGFR) of 50 mL/min or less within 14 days before the procedure.
- Subject has uncorrectable blood clotting disorder.
- Subject has an INR value of 2.0 or higher within 14 days before the procedure.
- Subject has had prostate removal surgery (prostatectomy).
- Subject has acute prostatitis.
- Subject has chronic prostatitis or chronic pelvic pain syndrome diagnosis or treatment history.
- Subject had a urinary tract infection within 3 months before the procedure.
- Subject has bladder stones.
- Subject is catheter-dependent or has history of self-catheterization.
- Subject has prostatic calcifications in the planned treatment area.
- Subject has permanent radioactive implants in rectal wall.
- Subject has had major abdominal or rectal surgery preventing prostate visualization.
- Subject had prior locoregional therapy such as Rezum, laser, Urolift, TURP emboli, or radiation.
- Subject plans locoregional therapy within 6 months after the procedure.
- Subject has active cancer (not in remission for 2 years) other than non-melanoma skin cancer.
- Subject is currently enrolled in another drug or device trial that could interfere with this study.
- Investigator judges histotripsy is not suitable for the subject.
- Subject has any condition that could risk safety or protocol compliance.
- Subject's prostate is outside treatment device parameters per user guide.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
K
Kelly Erickson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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