The Durham, North Carolina-based company said the 2-year study is slated to enroll 80 patients at multiple sites to evaluate the safety and efficacy of the targeted radiation device for use with patients undergoing surgery for pancreatic cancer.
The CivaSheet is a flexible, implantable device that emits targeted, low-dose Palladium-103 to cancerous tissue. The device is designed to be implanted in a 15 minute procedure after surgery and is almost completely absorbed by the body, so no follow-up visit is necessary to remove the device, according to CivaTech.
CivaTech won FDA approval for its device in 2014.
The company reports that 45,000 people are diagnosed with pancreatic cancer annually in the U.S. The standard of care for pancreatic cancer includes radiation, but the dose is limited because of radiation’s toxic side effects.
“The option to treat patients with a directional radiation implant using the CivaSheet may allow us to increase the safe dose of radiation in this setting, controlling disease that would otherwise come back,” principal investigator Dr. Joshua Meyer said in prepared remarks. “Our team is eager to begin studying this device on a clinical trial.”