AngioDynamics has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption application to begin the RELIEF clinical trial of the NanoKnife system.
The single-arm, prospective trial is set to evaluate the safety and effectiveness of irreversible electroporation (IRE) using NanoKnife as a potential minimally invasive treatment for men with benign prostatic hyperplasia (BPH).
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BPH is a urologic condition that can lead to lower urinary tract symptoms such as frequency, urgency, weak stream, and incomplete bladder emptying.
The study will enrol up to 40 participants across a maximum of five clinical sites in the US.
According to AngioDynamics, the primary effectiveness endpoint will be the change in International Prostate Symptom Score (IPSS) at six months post-procedure while the main safety endpoint will measure the incidence and severity of device-related adverse events over the same period.
Patients will continue to be followed for up to five years to assess secondary outcomes.
The NanoKnife system is currently cleared in the US for surgical ablation of soft tissue, including prostate tissue.
In earlier clinical experience with IRE in the prostate, clinicians observed improvements in urinary symptoms for patients treated for intermediate-risk prostate disease.
This observation, the company reported, informed the rationale for investigating NanoKnife in men with BPH through the RELIEF study.
AngioDynamics scientific and clinical affairs senior vice-president Juan Carlos Serna said: “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.
“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.”
The RELIEF study will be led by co-principal investigator Felix Cheung of Memorial Sloan Kettering Cancer Center.
NanoKnife remains an investigational device for the treatment of BPH and is limited by US law to investigational use.
Last month, AngioDynamics reported two-year findings from the PRESERVE pivotal trial, showing durable outcomes for the NanoKnife system in treating intermediate-risk prostate cancer.
