Surefire Medical, Inc. today announced that it has completed enrollment in the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial. This randomized prospective study investigates the feasibility and benefits of performing Selective Internal Radiation Therapy (SIRT), or radioembolization, without the need to place permanent coils.
SIRT is a form of radiation therapy generally used for selected patients with hepatic cell carcinoma or liver metastasis. In the study, half of the patients will have permanent embolic coils placed while the other half will undergo treatment with the Surefire Infusion System without coiling.
The study's primary endpoint is fluoroscopy time. Secondary endpoints are procedure time, radiation dose and contrast dose.
"Clinical studies show that SIRT can increase the overall survival without adversely affecting the patient's quality of life," said Aravind Arepally, M.D., Chief Scientific Officer and Chairman of Surefire's Scientific Advisory Board. "The goal of this study is to see if this complex, cumbersome workflow can be significantly improved by reducing procedure time and if radiation exposure to both the physician and patient can also be reduced."
Thirty patients have been enrolled at Mount Sinai Hospital in NYC. Principal investigators are Aaron Fischman, M.D. and Rahul Patel, M.D.
Surefire Medical's novel anti-reflux infusion system is a first-in-class medical device designed to maximize direct-to-tumor delivery of cancer-fighting agents and eliminate reflux. In SIRT treatment and in chemoembolization with Drug Eluting Beads, the unique tip dynamically expands to the vessel walls in reverse flow, potentially reducing damage to healthy tissue while maximizing the dose delivered directly to the target.
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