EndoPulse System for Endoscopic Ultrasound-Guided Therapy of Pancreatic Carcinoma

描述(申请人提供)：BioElectrMed正在开发一种名为EndoPulse的新医疗设备，该设备与回声内窥镜一起工作，提供纳秒脉冲电场疗法来治疗胰腺癌以及肾脏和肝脏的病变。EndoPulse“旨在穿透胃壁进入胰腺癌，然后在肿瘤两侧扩展电极阵列。我们还在开发一种高电压模型的PulseCure“纳秒脉冲发生器，它可以在两个电极阵列之间产生30千伏/厘米的电流，使整个肿瘤暴露在这个磁场强度下。我们已经确定，500个脉冲，长100 ns，幅度30千伏/厘米，在电极之间触发所有人类肿瘤细胞的凋亡，并使它们在两周内自毁。我们建议完成EndoPulse“和PulseCure”原型的设计和测试，并根据GMP制造最终版本，用于人体临床试验。在向FDA提交临床试验所需的研究设备豁免(IDE)申请之前，这两种仪器将被用于消融猪的小范围胰腺，以证明其安全性和有效性。一旦IDE获得批准，我们将在斯坦福大学医学中心进行一项有6名患者参加的可行性临床试验，由Ann Chen博士和Subhas Banerjee博士担任该试验的联合首席研究员。这两位胃肠病专家每月接待3-4名不能切除的胰腺癌患者，目前还没有有效的治疗方法。如果PulseCure“-EndoPulse”系统能够可靠地消融胰腺癌，它将为胰腺癌提供第一种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.