RenovoRx Begins Post-market Registry StudyRenovoRx Begins Post-market Registry Study
RenovoRx Begins Post-market Registry Study
RenovoRx has announced the opening of its post-market registry study, which will assess patient survival and clinical outcomes of the RenovoCath catheter when used to deliver gemcitabine and other chemotherapeutic agents to pancreatic tumors. The study will include up to 10 medical centers across the U.S. and will follow up to 100 patients with locally advanced pancreatic cancer. RenovoCath is FDA cleared for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
The primary objectives of the post-market registry study are to evaluate patient survival, including tracking the potential to provide a surgical option to remove the tumor. The study will also further analyze and define potential selection criteria for patients who may benefit from intra-arterial chemo-embolization of pancreatic tumors.
Studies indicate that systemically delivered chemotherapy does not effectively penetrate pancreatic tumors and that drug penetration is key to patient response and survival. And according to lead investigator, Dr. Alexander Rosemurgy, patients experience painful side effects when the chemotherapy is delivered systemically. “With this directed therapy, we can give very, very high levels of chemotherapy … into the tumors and yet have body levels which are very, very acceptable to the patients.”