AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the Company has completed patient enrollment in its European prospective NanoKnife® System trial (ONC-208) for the treatment of locally advanced unresectable pancreatic cancer.
The purpose of this Company-sponsored trial is to evaluate the safety and feasibility of the NanoKnife System for the treatment of Locally Advanced Unresectable Pancreatic Cancer.
Ten subjects at Policlinico G.B. Rossi, University of Verona, Verona, Italy, have been treated in the study, titled, “NanoKnife Low Energy Direct Current (LEDC) System in Subjects with Locally Advanced Unresectable Pancreatic Cancer.” It is being conducted by Professor Claudio Bassi, Policlinico G.B. Rossi, University of Verona, Department of Surgery, in Verona, Italy.
Eligibility was based on subjects having tumors of a size no greater than 4 cm and their being unresponsive to chemotherapy as demonstrated with either computed tomography (CT) or magnetic resonance (MR) imaging, and having not taken any chemotherapy agents within 14 days of treatment with the NanoKnife System. The primary endpoint is safety determined at 90-days post treatment, with efficacy as a secondary endpoint, also determined at 90-days, through tumor response assessment with imaging.
“Through this, and other studies, we are building a body of evidence that helps us better understand the NanoKnife System’s capabilities,” said President and Chief Executive Officer Joseph DeVivo. “We look forward to seeing published scientific results from this European pancreas trial in the next six to nine months.”
Nanoknife is CE marked and FDA approved. FDA 510(k) clearance is for “surgical ablation of soft tissue”, although the product has not received clearance for the therapy or treatment of any specific disease or condition. Studies such as this one are no doubt helpful to the company to gain direct therapeutic indications in the United States.