EndoPulse System for Endoscopic Ultrasound-Guided Therapy of Pancreatic Carcinoma

用于内镜超声引导治疗胰腺癌的 EndoPulse 系统

基本信息

批准号：
8538887
负责人：
RICHARD Lee NUCCITELLI
金额：
$ 114.16万
依托单位：
BIOELECTROMED CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-01 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8538887
关键词：
Ablation Academic Medical Centers Accounting Aftercare Apoptosis Cancer Death Rates Clinical Clinical Trials Contracts Data Devices Diagnosis Dimensions Disease Electrodes Enrollment Evaluation Family suidae Gastroenterologist Gastroscopes Goals Grant Human In Vitro Incidence Induction of Apoptosis Joints Kidney Lead Lesion Life Liver Malignant neoplasm of pancreas Manufacturer Name Medical Device Medical Device Safety Medical center Modeling Modification Monitor Morbidity - disease rate Operative Surgical Procedures Pancreas Pancreatic carcinoma Patients Physiologic pulse Principal Investigator Rattus Research Safety Shapes Side Skin Cancer Solid Neoplasm Sterility Stomach System Technology Testing Tissues Ultrasonography Work Xenograft Model biomaterial compatibility chemoradiation design effective therapy electric field improved instrument lymph nodes minimally invasive mortality nanosecond neoplastic cell pancreatic neoplasm prototype research clinical testing response subcutaneous tumor tumor eradication verification and validation voltage

项目摘要

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.

描述（由申请人提供）：生物选择正在开发一种新的医疗装置，称为“内底”，与回声镜结合起作用，以提供纳米脉冲的电野战治疗，以治疗胰腺癌，以及肾脏和肝脏中的病变，以及在肾脏中均通过延伸的电气启动。肿瘤的侧面。 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完成和测试内部“和脉冲”原型，并在GMP下使用最终版本，用于人类临床试验。斯坦福大学医学中心的六个患者可行性试验，Ann Chen和Subhas Banerjee担任该试验的共同研究人员。这两位胃肠病医生每月接受3-4例患者，患有不可切除的胰腺癌，目前尚无有效的治疗。如果脉冲“ - 端子”系统可以可靠地烧毁胰腺癌，它将为胰腺癌提供首一种有效的非手术疗法，每年可以延长数以万计的患者的寿命。