FDA gives nod to feasibility study of NanoKnife IRE for benign prostatic hyperplasia

The FDA has approved a feasibility study assessing irreversible electroporation (IRE) using the NanoKnife System for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).¹

How is the RELIEF study designed?

The prospective, single-arm study, called RELIEF (NCT07640776), will evaluate the safety and preliminary efficacy of IRE delivered via the NanoKnife System as a tissue-sparing, minimally invasive management option for BPH-related symptoms. Investigators plan to enroll 40 patients at up to 5 clinical trial sites across the US. To be eligible for enrollment, patients must be aged 50 years or older and have an International Prostate Symptom Score (IPSS) of 13 or higher, a post-void residual of 250 mL or less, and a prostate volume between 30 cc and 80 cc.²

The primary efficacy end point is the mean change in IPSS from baseline to 6-months post-procedure. The primary safety end point is the incidence and severity of device-related adverse events through 6 months. Participants will be following for up to 5 years to assess secondary end points such as change in IPSS Quality of Life score, change in maximum urinary flow rate, change in post-void residual, change in sexual function, and change in ejaculatory dysfunction, all assessed across various time points.

“The RELIEF study was designed with scientific rigor at its core,” said principal investigator Felix Cheung, MD, urologic surgeon at Memorial Sloan Kettering Cancer Center, in a news release on the study.¹ “The study incorporates validated, well-established end points such as IPSS, uroflowmetry, and quality-of-life measures, alongside careful monitoring of sexual function and long-term durability through 5 years of follow-up. This thoughtful, methodical approach will generate the high-quality evidence needed to determine whether IRE can offer men with BPH/LUTS a non-resecting alternative with meaningful functional preservation.”

What is IRE?

The NanoKnife System is cleared in the US for surgical ablation of prostate tissue. IRE is a nonthermal tissue-ablation technique that uses short, high-voltage electrical pulses to create permanent nanopores in cell membranes, resulting in cell death while theoretically minimizing collateral thermal injury to adjacent structures.

According to AngioDynamics, “In prior clinical experience with IRE in the prostate, physicians observed meaningful improvements in urinary symptoms associated with BPH in patients treated for intermediate-risk prostate disease, an observation that provided clinical rationale for the RELIEF study.”

In the study, participants will undergo transperineal IRE treatment of the prostate transition zone using the NanoKnife System under transrectal ultrasound guidance and general anesthesia. According to the study design, treatment planning aims to preserve surrounding structures, including the urethra, neurovascular bundles, and external urinary sphincter.

“The NanoKnife System has an established role in the treatment of men with intermediate-risk prostate disease. Physicians have consistently reported meaningful improvements in urinary symptoms following IRE with the NanoKnife System, a signal we believe warrants further clinical evaluation,” said Juan Carlos Serna, AngioDynamics Senior Vice President, Scientific and Clinical Affairs, in the news release.¹ “The RELIEF study will generate the initial safety and effectiveness data needed to advance IRE as a tissue-sparing solution for the millions of men living with BPH.”

REFERENCES

1. AngioDynamics receives FDA IDE approval for RELIEF feasibility study evaluating NanoKnife IRE platform as minimally invasive treatment for benign prostatic hyperplasia (BPH). News release. AngioDynamics. June 17, 2026. Accessed June 18, 2026. https://www.businesswire.com/news/home/20260617790711/en/AngioDynamics-Receives-FDA-IDE-Approval-for-RELIEF-Feasibility-Study-Evaluating-NanoKnife-IRE-Platform-as-Minimally-Invasive-Treatment-for-Benign-Prostatic-Hyperplasia-BPH 

2. Irreversible electroporation (IRE) for the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) (RELIEF). ClinicalTrials.gov. Last updated June 11, 2026. Accessed June 18, 2026. https://clinicaltrials.gov/study/NCT07640776