The purpose of the trial is to evaluate the safety and efficacy of the NanoKnife system for the treatment of early-stage hepatocellular carcinoma. Eligibility was based on subjects having one to three tumors of a size no greater than 3 cm. Study subjects are allowed one retreatment with the NanoKnife system.
“We look forward to the scientific findings from this prospective clinical trial,” said Joseph DeVivo, AngioDynamics’ president and CEO. “The clinical results will be of particular interest as the subjects have not been treated with other modalities, meaning any response obtained is directly attributable to the NanoKnife system.”
During the study, there have been no 30-day mortalities and no serious adverse events associated with the system. Doctors reported three serious adverse events not related to treatment. The primary endpoint is tumor response assessment at 30-days post treatment with imaging, with subjects followed to end-of-life to determine overall survival as a secondary endpoint.
In all, 26 subjects at five European sites have been treated in the study that is being conducted by professor Jordi Bruix of the Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona, Spain, and professor Riccardo Lencioni of the University of Pisa School of Medicine, Italy.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the treatment or therapy of a specific disease or condition.
