AngioDynamics has received approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application, enabling the company to initiate the RELIEF clinical trial evaluating the NanoKnife System as a potential treatment for benign prostatic hyperplasia (BPH).

The prospective, single-arm study will assess the safety and effectiveness of irreversible electroporation (IRE) using the NanoKnife System as a minimally invasive approach for men suffering from BPH, a common condition characterised by prostate enlargement that can cause bothersome urinary symptoms including increased frequency, urgency, weak urine flow and incomplete bladder emptying.

The RELIEF trial is expected to enrol up to 40 patients across a maximum of five clinical sites in the United States.

The study's primary effectiveness endpoint will evaluate changes in the International Prostate Symptom Score (IPSS) six months after treatment, while the primary safety endpoint will assess the incidence and severity of device-related adverse events over the same period.

Participants will continue to be monitored for up to five years to evaluate longer-term clinical outcomes and durability of treatment effects.

The NanoKnife System is currently cleared in the US for the surgical ablation of soft tissue, including prostate tissue. According to AngioDynamics, previous clinical experience with IRE in prostate treatments revealed improvements in urinary symptoms among patients treated for intermediate-risk prostate disease. 

These observations provided the scientific rationale for investigating the technology as a potential treatment for BPH.

Juan Carlos Serna, Senior Vice President, Scientific and Clinical Affairs at AngioDynamics, said the company believes the observed improvements in urinary function warrant further clinical evaluation. 

He noted that the RELIEF study will generate the initial safety and effectiveness data needed to assess whether IRE can emerge as a tissue-sparing treatment option for the millions of men affected by BPH.

The trial will be led by Dr. Felix Cheung of Memorial Sloan Kettering Cancer Center, who will serve as co-principal investigator.

NanoKnife remains an investigational device for the treatment of BPH and is currently restricted to investigational use under US regulations.