Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

NCT07640776 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-ONC-03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).

Conditions

Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

Keywords

Lower Urinary Tract Symptoms (LUTS); Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure

  The primary safety endpoint is the incidence and severity of device-related adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  From treatment through 6 months post-procedure

• Mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure

  The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure, assessing improvement in lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH)

  From baseline through 6 months post-procedure

Secondary Outcomes (14)

• Technical success

  Immediately after the procedure

• Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure

  From treatment through 12 months post-procedure

• Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure

  From treatment through 6 months post-procedure

• Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure

  From treatment through 12 months post-procedure

• Rate of ablations that were completed successfully per the treating physician

  Immediately after the procedure

Study Arms (1)

Irreversible Electroporation

EXPERIMENTAL

Treatment with the NanoKnife System

Device: Irreversible Electroporation

Interventions

Irreversible Electroporation DEVICE

Treatment with the NanoKnife System for ablation of prostate tissue. The procedure will be performed under general anesthesia using transrectal ultrasound (TRUS) guidance. Electrodes will be placed transperineally into predefined treatment zones of the prostate based on imaging and prostate anatomy. Treatment planning will be tailored to target the transition zone bilaterally while preserving key structures, including the neurovascular bundles, external sphincter, and urethra. Electrical pulses will be delivered according to device specifications to achieve focal non-thermal ablation of tissue.

Irreversible Electroporation

Eligibility Criteria

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

You may qualify if:

• Male, age ≥50 years.
• Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
• International Prostate Symptom Score (IPSS) ≥13 at screening.
• Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
• Post-void residual (PVR) ≤250 mL.
• Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).
• Willing and able to comply with all study procedures and follow-up requirements.
• Able to provide written informed consent.
• Life expectancy ≥10 years.

You may not qualify if:

• Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
• Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
• Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
• Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
• Presence of urethral stricture or bladder neck contracture.
• Patients with a history of pelvic radiation/irradiation.
• Patients with compromised renal function (serum creatinine level \>1.8 mg/dL or upper-tract disease).
• Obstructing median lobe intravesical prostatic protrusion (IPP) with \>1 cm assessed by TRUS or MRI.
• Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.
• Active need of catheterization.
• Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).
• History of bladder cancer or other urological malignancy.
• Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.
• Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.
• Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Elizabeth Manning Sr. Director, Clinical Affairs

CONTACT

339-237-2765; liz.manning@angiodynamics.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

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06