EndoPulse System for Endoscopic Ultrasound-Guided Therapy of Pancreatic Carcinoma

描述（由申请人提供）：BioElectroMed正在开发一种名为“EndoPulse”的新型医疗器械，该器械与超声内镜配合使用，可提供纳秒脉冲电场治疗，以治疗胰腺癌以及肾脏和肝脏病变。EndoPulse”的设计是在肿瘤两侧延伸电极阵列之前穿透胃壁进入胰腺癌。我们还在开发PulseCure”纳秒脉冲发生器的高电压模型，它可以在两个电极阵列之间产生30 kV/cm的电压，将整个肿瘤暴露在这种场强下。我们已经确定，施加500个100 ns长和30 kV/cm振幅的脉冲会触发电极之间所有人类肿瘤细胞的凋亡，并导致它们在两周内自毁。我们建议完成EndoPulse”和PulseCure”原型的设计和测试，并根据GMP生产最终版本，用于人体临床试验。然后，这两种器械将用于消融猪胰腺的小区域，以证明安全性和有效性，然后向FDA提交临床试验所需的试验用器械豁免（IDE）申请。一旦IDE获得批准，我们将在斯坦福大学医学中心开展一项6例患者的可行性临床试验，Ann Chen博士和Subhas Banerjee博士将担任本试验的共同主要研究者。这两位胃肠病学家每月接受3-4例患有不可切除胰腺癌的患者，目前尚无有效治疗方法。如果PulseCure”-EndoPulse”系统能够可靠地消融胰腺癌，它将为胰腺癌提供首个有效的非手术治疗，每年可延长数万名患者的生命。 公共卫生相关性：这项研究将开发一种突破性的微创方法来治疗胰腺肿瘤，目前的治疗方案很差，而且成本很高。这种称为EndoPulse的新医疗设备可以很容易地扩展到治疗其他局灶性内部病变，特别是肝脏，肾脏和淋巴结。EndoPulse通过超声内镜中的超声成像引导到内部肿瘤，并施加超短电脉冲，导致肿瘤细胞自毁。

DESCRIPTION (provided by applicant): BioElectroMed is developing a new medical device called the EndoPulse" that works in conjunction with an echoendoscope to deliver nanosecond pulsed electric field therapy to treat pancreatic carcinoma as well as lesions in the kidney and liver. The EndoPulse" is designed to penetrate through the stomach wall into a pancreatic carcinoma before extending an electrode array on both sides of the tumor. We are also developing a high voltage model of the PulseCure" nanosecond pulse generator that can generate 30 kV/cm between the two electrode arrays, exposing the entire tumor to this field strength. We have determined that the application of 500 pulses 100 ns long and 30 kV/cm in amplitude triggers apoptosis in all the human tumor cells between the electrodes and causes them to self-destruct within two weeks. We propose to complete the design and testing of both the EndoPulse" and PulseCure" prototypes and have the final versions manufactured under GMP for use in human clinical trials. These two instruments will then be used to ablate small regions of pancreas in pigs to demonstrate safety and efficacy prior to submitting the application to the FDA for an Investigational Device Exemption (IDE) required for the clinical trial. Once the IDE is granted, we will conduct a six-patient feasibility clinical trial at Stanford University Medical Center with Drs. Ann Chen and Subhas Banerjee acting as Co-Principal Investigators of this trial. These two gastroenterologists receive 3-4 patients per month with non-resectable pancreatic carcinomas for which there is currently no effective therapy. If the PulseCure"-EndoPulse" system can reliably ablate pancreatic carcinomas, it would offer the first effective, non-surgical therapy for pancreatic cancer that could extend the lives of tens of thousands of patients each year. PUBLIC HEALTH RELEVANCE: This research will develop a breakthrough, minimally invasive approach to the treatment of pancreatic tumors for which current treatment options are poor and costly. This new medical device called the EndoPulse is readily extendable to treat other focal internal lesions especially in the liver, kidney and lymph nodes. The EndoPulse is guided to the internal tumor by ultrasound imaging in an echoendoscope and applies ultrashort electrical pulses that cause the tumor cells to self-destruct.