An interventional study of Irreversible Electroporation in Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), sponsored by Angiodynamics, Inc.. Not yet recruiting. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Angiodynamics, Inc. · Not applicable, Interventional, and Treatment
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
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.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 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)
Time frame: From baseline through 6 months post-procedure
Technical success
The technical success of the procedure, defined to be successful energy delivery per the treating physician
Time frame: Immediately after the procedure
Incidence and severity of device-related adverse events (AEs) 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
Time frame: From treatment through 12 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) 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
Time frame: From treatment through 6 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) 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.
Time frame: From treatment through 12 months post-procedure
Rate of ablations that were completed successfully per the treating physician
Rate of ablations that were completed successfully per the treating physician
Time frame: Immediately after the procedure
Change in IPSS 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
Time frame: 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
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 maximum urinary flow rate (Qmax) 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.
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
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 prostate volume 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
Time frame: From baseline to 6, 12, 24, 36, 48 and 60 months
Incidence of unplanned BPH-related interventions within 12 months following the procedure
Incidence of unplanned BPH-related interventions (e.g., catheterization, medication initiation, surgery) within 12 months following the procedure
Time frame: 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
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 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
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 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
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Lower Urinary Tract Symptoms →