This pilot study of the NanoKnife System for the ablation of prostate cancer has been initiated by AngioDynamics, Inc., to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in low and intermediate risk subjects with organ-confined prostate cancer and a low risk of recurrence. The study will also determine the NanoKnife System treatment morbidity profile by evaluating urinary and erectile function.

The overall goal of the study will be to determine the feasibility of the NanoKnife System as a focal therapy and lead to a larger pivotal study for further research.

Co-principal Investigators

The co-principal investigators for this study are:

Dr. Murugesan Manoharan from Miami Cancer Institute
Dr. Derek J. Lomas from The Mayo Clinic
Dr. Srinivas Vourganti from Rush University Medical Center.

About NanoKnife System and IRE Technology

Irreversible Electroporation, also known as IRE, is a technique utilizing electrical pulses to create permanent nanopores in the cell membrane to disrupt cellular homeostasis. This disruption initiates an apoptotic-like effect which leads to permanent cell death.1

The IRE technology used in this pilot study is known as the NanoKnife System. The NanoKnife System is an ablative device that uses non-thermal energy to deliver a series of high voltage direct current electrical pulses between electrodes placed within a target area of tissue. The NanoKnife System can use anywhere from 2-6 probes per procedure. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. Currently, it has not received clearance for the therapy or treatment of any specific disease or condition.

Cited References

1 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. (2010);4(SUPPL. 1):99–104. doi: 10.5009/gnl.2010.4.S1.S99.

Important Risk Information

AngioDynamics, the AngioDynamics logo, NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. GL/ON/WP/587 REV 01 12/2020