DIRECT, led by Co-Principal Investigators – Govindarajan Narayanan, MD, Chief of Interventional Oncology at Miami Cancer Institute and Robert C.G. Martin, MD, PhD, Surgical Oncology at the University of Louisville, is looking to better patient care by uncovering potentially new treatment options for those suffering with locally advanced pancreatic cancer.
DIRECT is a clinical study composed of two protocols that will evaluate the efficacy and safety of using Irreversible Electroporation (IRE) technology to ablate malignant pancreatic tumors in people diagnosed with stage III pancreatic cancer. The trial is set up to evaluate both real-world results from the Registry, and additional results from the Randomized Control Trial. The unique trial design is made possible by the use of Electronic Medical Record (EMR) technology to directly capture study data, thus, reducing the burden on patients and clinicians.
The clinical study is currently enrolling patients. If you are a physician or clinical staff member that has a potentially qualifying patient or would like to learn more about getting involved with the study, please call our support line at +1 (800) 584-7608 or email us at email@example.com.
Irreversible Electroporation (IRE) is a technique using a non-thermal energy to create permanent nanopores in the cell membrane to disrupt cellular homeostasis. The disruption of cellular homeostasis initiates an apoptotic-like effect which leads to permanent cell death. After delivering a sufficient number of high voltage pulses, the cells within the electrical field will be irreversibly damaged.5
The IRE technology used in DIRECT is known as the NanoKnife System. A NanoKnife procedure is an ablation procedure that involves the delivery of a series of high voltage direct current electrical pulses between electrodes placed within a target area of tissue. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.6
DIRECT will evaluate the use of NanoKnife IRE technology on the treatment of malignant tumors in the pancreas. If you are a physician and would like to get involved with the study, please call our support line at +1 (800) 584-7608 or email us at firstname.lastname@example.org.
AngioDynamics offers device training for the NanoKnife System through our Medical Affairs and Clinical Specialist teams. If you would like to get more information about NanoKnife IRE device trainings or workshops, please reach out to email@example.com
1 Cancer Facts & Figures 2020. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annualcancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf Accessed February 26, 2020.
2 What Is Pancreatic Cancer? American Cancer Society. https://www.cancer.org/cancer/pancreatic-cancer/about/what-is-pancreatic-cancer.html. Accessed February 26, 2020.
3 Pancreatic Cancer Stages. American Cancer Society. https://www.cancer.org/cancer/pancreaticcancer/detection-diagnosis-staging/staging.html. Accessed February 26, 2020.
4 Pancreatic Cancer - Stages. Cancer.Net. https://www.cancer.net/cancer-types/pancreaticcancer/stages. Published May 23, 2018. Accessed February 26, 2020.
5 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. (2010);4(SUPPL. 1):99–104. doi: 10.5009/gnl.2010.4.S1.S99.
DIRECT Study Co-principal Investigators
Dr Robert C.G. Martin, MD, PhD, Surgical Oncology at the University of Louisville
Dr Govindarajan Narayanan, MD, Chief of Interventional Oncology at Miami Cancer Institute
AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. GL/ON/WP/105 Rev 01 02/20x