At a glance
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Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
In Brief
A clinical study evaluating Irreversible Electroporation for Prostate Cancer. Completed, enrolled 121 participants across 17 sites.
Signals
Detailed Summary
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Study Details
Timeline
Arms & Interventions
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Interventions
IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.