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

NCT07214675 | Recruiting FDA Device

• 1 other identifier: CSP5895
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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). \[Clinical Events Committee Adjudicated\]

  30 days post histotripsy procedure

Study Arms (1)

HistoSonics Edison System

EXPERIMENTAL

Device: HistoSonics Edison System

Interventions

HistoSonics Edison System DEVICE

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.

Also known as: Histotripsy

HistoSonics Edison System

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Kelly Erickson

CONTACT

612-965-8895; Kelly.Erickson@histosonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective multi-center, single-arm, feasibility trial.

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 9, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)