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

NCT07640776 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-11

No results posted yet for this study

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)

Interventions

DEVICE

Irreversible Electroporation

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.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-12-31
Completion
2031-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640776 on ClinicalTrials.gov