AngioDynamics has enrolled the first patient in its NanoKnife Irreversible Electroporation (IRE) ‘Data IRE Cancer Treatment’ clinical study (DIRECT).
AngioDynamics said that the DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer.
Tthe enrollment follows an approval from the United States Food and Drug Administration’s (FDA) for the AngioDynamics’ investigational device exemption (IDE) application.
AngioDynamics senior vice president and Oncology general manager Brent Boucher said: “The enrollment of our first patient soon after receiving FDA approval is a strong signal that clinicians are eager to evaluate treatment alternatives that improve the dismal prognosis for Stage III pancreatic cancer patients.
“We look forward to confirming that our proprietary NanoKnife technology offers a compelling alternative to the current standard of care and believe that this study will provide a pivotal dataset for claims and reimbursement purposes.”
The DIRECT clinical study features a comprehensive data collection strategy, that provides clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians.
The company claimed that the next-generation study is classified as a Category B IDE by the FDA, which allows participating sites to secure coverage for procedures performed in addition to any related routine costs.
DIRECT Study Co-Principal Investigator and Surgical Oncologist Robert C.G. Martin said: “We are pleased to be the first enrolling site. The DIRECT Study represents an important milestone in the standardization of care for patients with Stage III pancreatic cancer.
“Our goal is to generate important data that should standardize and optimize the use of IRE in the treatment of locally advanced pancreatic cancer, significantly improving outcomes for patients with this late-stage diagnosis.”
The DIRECT Study consists of a Randomized Controlled Trial at up to 15 sites, as well as a Real-World Evidence, next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm.
AngioDynamics has launched AngioDIRECT.com as part of the DIRECT study, to facilitate the enrollment of participants, and provide the patients and their families with information about pancreatic cancer and other details about the study.