Edison System histotripsy treatment for enlarged prostate (BPH)

The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy

This will test whether the HistoSonics Edison System's histotripsy procedure is safe for men 50 and older with symptomatic enlarged prostate (BPH).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: HistoSonics, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Shatin)
• Trial ID: NCT07214675 on ClinicalTrials.gov

What this trial studies

This prospective, multi-center, single-arm feasibility trial tests the safety of the HistoSonics Edison System to perform histotripsy for men with symptomatic BPH. Subjects will have the index histotripsy procedure, imaging within 72 hours, and clinical follow-up at 30, 90, and 180 days. Key enrollment criteria include age ≥50, I‑PSS ≥15, prostate volume 30–150 mL, Qmax ≤15 mL/s with adequate voided volume, BMI <27, and acceptance of possible loss of ejaculatory function and general anesthesia. Treatment targeting is guided by ultrasound/CT/MR with a required ≥1 cm margin from the rectum.

Who should consider this trial

Good fit: Men aged 50 or older with symptomatic BPH (I‑PSS ≥15), prostate volume 30–150 mL, Qmax ≤15 mL/s with ≥125 mL voided volume, BMI <27, an adequate acoustic window, and willingness to undergo general anesthesia and accept possible loss of ejaculatory function.

Not a fit: Patients with prostates smaller than 30 mL or larger than 150 mL, BMI ≥27, inadequate acoustic window or target tissue closer than 1 cm to the rectum, limited life expectancy, or who are unwilling to accept anesthesia or potential ejaculatory changes are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a minimally invasive, image-guided alternative for relieving urinary symptoms with potentially faster recovery than some surgical options.

How similar studies have performed: Early preclinical and first-in-human histotripsy work has shown promising safety signals and symptom improvements, but randomized or long-term comparative data are limited.

Eligibility criteria

Inclusion Criteria:

1. Subject is ≥ 50 years of age.
2. 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.
3. Subject is diagnosed with BPH.
4. Subject has a Body Mass Index (BMI) \< 27.
5. Subject has an I-PSS ≥ 15.
6. Subject has a prostate volume \> 30 mL and ≤ 150 mL.
7. Subject has a Qmax ≤ 15 mL/s with a voided volume of ≥ 125 mL during a uroflow test.
8. Subject accepts the potential loss of ejaculatory function.
9. Subject can tolerate general anesthesia. Index-Procedure Imaging Inclusion (Assessed day of procedure)
10. Subject has an adequate acoustic window to visualize the prostate using the HistoSonics Edison System.
11. Target treatment volume is ≥ 1 cm from the rectum as visualized on ultrasound, CT or MR imaging.

Exclusion Criteria:

1. Subject has a life expectancy of less than one (1) year.
2. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
3. Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
4. Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
5. Subject has uncorrectable coagulopathy.
6. Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤14 days prior to the planned index procedure date.
7. Subject has had a prostatectomy.
8. Subject has acute prostatitis.
9. Subject has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome.
10. Subject has had a urinary tract infection (UTI) ≤ 3 months prior to the planned index procedure date.
11. Subject has bladder stones.
12. Subject is catheter dependent or has a history of intermittent self-catheterization.
13. Presence of prostatic calcifications in the planned treatment volume (PTV).
14. Presence of permanent radioactive implants in the rectal wall.
15. Subject has has a major abdominal or rectal surgery that inhibits visualization of the prostate.
16. Subject has undergone prior locoregional therapy (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
17. Subject has planned locoregional therapy 6 months post index procedure (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
18. Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
19. 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.
20. In the investigator's opinion, histotripsy is not a treatment option for the subject.
21. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
22. Subject's prostate is not treatable by the System's working ranges (refer to User Guide).

Where this trial is running

Shatin

• Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)

Study contacts

• Study coordinator: Kelly Erickson

Conditions Benign Prostatic Hyperplasia