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

June 9, 2026 updated by: Angiodynamics, Inc.
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
  2. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
  3. Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
  4. Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
  5. Presence of urethral stricture or bladder neck contracture.
  6. Patients with a history of pelvic radiation/irradiation.
  7. Patients with compromised renal function (serum creatinine level >1.8 mg/dL or upper-tract disease).
  8. Obstructing median lobe intravesical prostatic protrusion (IPP) with >1 cm assessed by TRUS or MRI.
  9. Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.
  10. Active need of catheterization.
  11. Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).
  12. History of bladder cancer or other urological malignancy.
  13. Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.
  14. Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.
  15. 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.
  16. Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation.
  17. Desire to preserve future fertility.
  18. Severe or uncontrolled comorbidities (e.g., NYHA class III/IV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes.
  19. Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment.
  20. Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Irreversible Electroporation
Treatment with the NanoKnife System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure
Time Frame: From treatment 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
Time Frame: From baseline through 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Immediately after the procedure
The technical success of the procedure, defined to be successful energy delivery per the treating physician
Immediately after the procedure
Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure
Time Frame: From treatment through 12 months post-procedure
The incidence and severity of device-related adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
From treatment through 12 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure
Time Frame: From treatment through 6 months post-procedure
The incidence, relatedness, seriousness, and severity of all 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
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure
Time Frame: From treatment through 12 months post-procedure
The incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
From treatment through 12 months post-procedure
Rate of ablations that were completed successfully per the treating physician
Time Frame: Immediately after the procedure
Rate of ablations that were completed successfully per the treating physician
Immediately after the procedure
Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Time Frame: From baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure, assessing durability of symptom improvement over time
From baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months, measured by non-invasive uroflowmetry.
From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months.
Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months.
Change in prostate volume from baseline to 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline to 6, 12, 24, 36, 48 and 60 months
Change in prostate volume as assessed by transrectal ultrasound (TRUS) or MRI from baseline to 6, 12, 24, 36, 48 and 60 months
From baseline to 6, 12, 24, 36, 48 and 60 months
Incidence of unplanned BPH-related interventions within 12 months following the procedure
Time Frame: From treatment through 12 months post-procedure
Incidence of unplanned BPH-related interventions (e.g., catheterization, medication initiation, surgery) within 12 months following the procedure
From treatment through 12 months post-procedure
Change in sexual function as measured by the International Index of Erectile Function (IIEF-5) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in sexual function as measured by the International Index of Erectile Function (IIEF-5) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in ejaculatory dysfunction as measured by the Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD-SF) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in ejaculatory dysfunction as measured by the Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD-SF) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in health-related quality of life (HRQoL) as measured by the EQ-5D-5L and EQ VAS instrument from baseline to 6, 12, 24, 36, 48 and 60 months
Time Frame: From baseline to 6, 12, 24, 36, 48 and 60 months
Change in health-related quality of life (HRQoL) as measured by the EQ-5D-5L and EQ VAS instrument from baseline to 6, 12, 24, 36, 48 and 60 months
From baseline to 6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angiodynamics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-ONC-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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