AngioDynamics, Inc. (NY, USA) has received approval from FDA to commence a trial assessing the NanoKnife® ablation system in the treatment of stage III pancreatic cancer, which will also include a real-world evidence (RWE) element. The Direct Irreversible Electroporation Cancer Treatment (DIRECT) study will comprise a randomized controlled trial (RCT) at up to 15 sites and a next-generation RWE registry at up to 30 sites.
“The DIRECT study design demonstrates our commitment to provide an option that addresses a pressing unmet need for patients with Stage III pancreatic cancer,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “We are confident that our comprehensive approach, crafted through a constructive dialogue with the FDA, will generate meaningful data for clinicians, patients, payors and other stakeholders who are equally committed to fighting this disease, and we are dedicated to the idea that the standard of care for this deadly disease can—and should—improve.”
The RWE component of the study is designed to collect data that can be provided to clinicians, patients and payors. Each site will involve a treatment arm and a control arm, and will treat approximately 250 patients per arm. The overall endpoint of the study is survival.