Saline Enhanced Radiofrequency Ablation for Liver Tumors

描述（由申请人提供）：肝癌是一个重要的和日益增长的健康问题。在美国，将有超过72，500例结直肠癌转移到肝脏。肝细胞癌（HCC）在美国也越来越受到关注，主要是由于丙型肝炎的增加。在过去的十年中，美国HCC的发病率翻了一番，达到17，550例，预计在未来十年内将再次翻一番。绝大多数患者将在5年内死亡。目前治疗肝癌的标准是手术切除，但只有约20%的患者符合此手术条件。经皮射频消融术是一种替代疗法。在这种疗法中，将一个小电极插入肿瘤中，然后用高功率高频电流加热肿瘤。这种疗法是一种特别有吸引力的替代切除术，因为它是廉价的，它具有低并发症的发生率。然而，这种疗法仅对小肿瘤有效-当治疗直径大于3-4 cm的肿瘤时无效。迫切需要一种能够治疗大肿瘤的系统，因为一半的患者在初次诊断时肿瘤大于3 cm，这些较大的肿瘤会降低预期寿命。我们建议完成我们的盐水增强射频（SERF）消融系统的开发，能够治疗大的肝脏肿瘤。我们的系统使用组织的射频加热，同时通过电极将热盐水注入组织。盐水的细胞外流动将热能对流更深地进入组织，以治疗比以前可能的更大的体积。我们的技术已经在体内产生了8 cm直径的热损伤。这些治疗体积是使用传统RF电极产生的治疗体积的20倍。我们将完成治疗系统和针的设计，并确认其符合医用电气安全标准（EN 60601 -1）、生物相容性（ISO-10993），并确认灭菌达到无菌保证水平（SAL）10（-6）。然后，我们将在MD安德森癌症中心、路易斯维尔大学、辛辛那提大学和西南医学中心开展多中心临床试验。临床试验完成后，我们将提交并获得510（k）许可，以便在美国销售SERF消融系统。

DESCRIPTION (provided by applicant): Liver cancer is a significant and increasing health concern. In the United States, there will be over 72,500 cases of colorectal cancer metastasized to the liver. Hepatocellular carcinoma (HCC) is also an increasing concern in the United States, primarily due to a rise in hepatitis C. The incidence of HCC in the United States has doubled to 17,550 cases over the last decade, and it is expected to double again over the next ten years. The vast majority of these patients will die within 5 years. The current standard for treating liver cancer is surgical resection, but only about 20% of patients are eligible for this procedure. Percutaneous radiofrequency ablation is one alternative therapy. In this therapy, a small electrode is inserted into the tumor and a high-power, high frequency electrical current heats the tumor. This therapy is a particularly attractive alternative to resection because it is inexpensive and it has a low incidence of complication. However, this therapy is only effective on small tumors-it is ineffective when treating tumors larger than 3-4 cm in diameter. A system capable of treating large tumors is critically needed since half of patients have tumors larger than 3 cm at initial diagnosis, and these larger tumors decrease life expectancy. We propose to complete the development of our saline-enhanced radiofrequency (SERF) ablation system capable of treating large liver tumors. Our system uses radiofrequency heating of tissue with simultaneous injection of hot saline through the electrode and into the tissue. The extracellular flow of saline convects the thermal energy deeper into the tissue to treat larger volumes than previously possible. Our technique has created 8 cm diameter thermal lesions in vivo. These treatment volumes are 20 times as large as those created with conventional RF electrodes. We will complete the design of our therapy system and needle and validate that it complies with medical electrical safety standards (EN60601-1), biocompatibility (ISO-10993), and validate the sterilization to a sterility assurance level (SAL) of 10(-6). We will then carry out a multi-center clinical trial at the MD Anderson Cancer Center, the University of Louisville, the University of Cincinnati and the Southwestern Medical Center. Upon completion of the clinical trial we will file and obtain 510(k) clearance to sell SERF ablation systems in the United States.