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endoppulse的新型医疗设备，该设备与回声内窥镜一起工作，提供纳秒脉冲电场治疗，用于治疗胰腺癌以及肾脏和肝脏病变。endoppulse的设计初衷是在将电极阵列延伸到肿瘤两侧之前，穿透胃壁进入胰腺癌。我们还在开发PulseCure“纳秒脉冲发生器”的高压模型，它可以在两个电极阵列之间产生30千伏/厘米的脉冲，使整个肿瘤暴露在这种场强下。我们已经确定，施加500个100ns长、30kv /cm振幅的脉冲，在电极之间触发所有人类肿瘤细胞凋亡，并使它们在两周内自毁。我们建议完成endoppulse和PulseCure原型的设计和测试，并根据GMP生产用于人体临床试验的最终版本。在向FDA提交临床试验所需的研究器械豁免（IDE）申请之前，这两种仪器将用于消融猪胰腺的小区域，以证明安全性和有效性。一旦IDE获得批准，我们将在斯坦福大学医学中心与dr。Ann Chen和Subhas Banerjee担任本次试验的联合首席研究员。这两位胃肠病学家每月接受3-4例不可切除的胰腺癌患者，目前尚无有效的治疗方法。如果PulseCure“- endpulse”系统能够可靠地消融胰腺癌，它将为胰腺癌提供第一个有效的非手术治疗方法，每年可以延长数万名患者的生命。

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.