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FrostBite - A Unique Catheter for Endoscopic Cryoablation

FrostBite - 用于内镜冷冻消融的独特导管

基本信息

批准号：
9984633
负责人：
John M BAUST
金额：
$ 0.18万
依托单位：
CELL PRESERVATION SERVICES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-06 至 2020-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9984633
关键词：
Ablation Address Adoption Antineoplastic Agents Biomedical Engineering Biotechnology Cancerous Carcinoma in Situ Cardiac ablation Catheters Cell Death Cells Cellular Stress Cholecalciferol Clinical Clinical Research Clinical Sciences Cold Therapy Colorectal Cancer Combined Modality Therapy Conduct Clinical Trials Cost Savings Coupled Cryosurgery Data Development Device or Instrument Development Devices Diagnosis Diagnostic Disease Drug Combinations Effectiveness Endoscopic Ultrasonography Engineering Evolution Family suidae Freezing Frostbite Gastroenterologist Goals Healthcare Systems Image Imagery In Situ Incidence Individual Intestinal Cancer Kidney Letters Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of esophagus Malignant neoplasm of gastrointestinal tract Malignant neoplasm of liver Malignant neoplasm of pancreas Medical Device Medicine Modeling Monitor Nature Needles Neoplasm Metastasis Operative Surgical Procedures Outpatients Pancreas Patients Peer Review Pharmaceutical Preparations Pharmacologic Substance Phase Procedures Property Prostate Protocols documentation Publishing Quality of life Recurrence Renal carcinoma Reporting Research Personnel Review Literature Risk Series Side Survival Rate Symptoms System Technology Testing Therapeutic Therapeutic Agents Thermal Ablation Therapy Time Tissue Engineering Tissue Model Tissues Translations Treatment Efficacy Treatment Protocols Universities analog base cancer diagnosis cancer therapy combat combinatorial cost cryobiology design effective therapy experience flexibility gastrointestinal imaging approach improved improved outcome in vivo innovation malignant stomach neoplasm medical schools miniaturize minimally invasive mortality new technology next generation novel novel therapeutics outcome forecast personalized medicine personalized strategies phase 1 study phase 2 study prototype real time monitoring sensor side effect success treatment optimization treatment strategy tumor

项目摘要

A growing number of studies have demonstrated that combinatorial approaches are providing a path for personalization of strategies to treat a wide array of disease states. While providing a promising path to revolutionize medicine, the evolution of personalized, minimally invasive, combinatorial therapies has been slowed as a result of technological limitations. As such, there is a pressing need for designing new devices to facilitate the development of paradigm changing, minimally invasive, approaches to treat diseased tissues in situ which enable trans-disciplinary strategies to combat disease. This Phase 2 project, which builds upon the success of the completed Phase 1, is designed to address this need through the development of a next generation flexible endoscopic compatible ablation catheter platform (FrostBite) for the treatment of various gastrointestinal cancers including pancreatic and liver cancer. This multi-functional platform will enable the application of multiple therapeutic and diagnostic approaches (pharmaceutical, ablation, among others) in a single device format which when combined with novel vitamin D3 analogs designed to increase the lethality of freezing, will provide for an enhanced treatment option for numerous cancers. The ability to deliver multi-parametric treatment regimens of the FrostBite catheter is enhanced by the incorporation of a novel deployable thermosensor to monitor ablation zone formation in real time. This, when combined with advanced imaging approach compatibility, including endoscopic ultrasound, MRI, and CT, will provide for unmatched control and visualization during a procedure. Phase 1 activities yielded a prototype 1.27mm needle tip catheter capable of delivering cryothermal insults to a target within 10 seconds creating a zone of destruction of ~2.5cm in less than 3 mins. Studies into combinatorial drug/thermal insults also demonstrated improved outcomes in tissue models. This Phase 2 is designed to 1) miniaturize and test the next generation endoscopic compatible cryocatheter, 2) integrate a novel in situ deployable multipoint thermal sensor to enable real time monitoring of the thermal profile of the target during ablation, 3) develop and evaluate a series of vitamin D3 analogs (commercial and novel), and test the optimal combination device and analog protocol in an ex vivo engineered tumor model and in in vivo studies. This project builds upon successful P1 studies, as well as others, and leverages the combined expertise of researchers from CPSI, University of Ottawa, Binghamton University, and Johns Hopkins School of Medicine to develop a new surgical device and adjunctive drug combination approach to more effectively treat cancers of the liver and pancreas. Once completed, this project will provide for an effective, minimally invasive treatment option for individuals suffering from these and other gastroenterological based cancers such as colorectal, stomach and esophageal cancer. Successful completion of this project will provide for a novel medical device enabling the development and application of advanced personalized treatment regimes for 100’s of thousands of patients who suffer from numerous gastrointestinal tissue disease states which are untreatable or inadequately treated with today’s state of the art devices yielding improved patient survival and quality of life.

越来越多的研究表明，组合方法正在为个性化的策略，以治疗各种疾病状态。同时提供了一条有希望的道路，革命性的医学，个性化，微创，组合疗法的发展，由于技术的限制，它的速度已经放慢。因此，迫切需要设计新的设备，以促进发展的范式变化，微创，方法，原位治疗病变组织，从而实现跨学科策略来对抗疾病。这个阶段第二阶段项目是在第一阶段成功的基础上进行的，旨在满足这一需求通过开发下一代柔性内窥镜兼容消融导管平台（FrostBite）用于治疗各种胃肠道癌症，包括胰腺癌和肝癌。该多功能平台将实现多种治疗和诊断应用，方法（药物，消融等）在一个单一的设备格式，当组合与新的维生素D3类似物，旨在增加冷冻的致死率，将提供一个为多种癌症提供更好的治疗选择。提供多参数治疗的能力 FrostBite导管的治疗方案通过引入一种新型的可展开的热传感器以真实的时间监测消融区域的形成。当它与先进的成像方法的兼容性，包括内窥镜超声、MRI和CT，将提供在手术过程中实现无与伦比的控制和可视化。第1阶段活动产生了1.27 mm原型针尖导管能够在10秒内将冷冻损伤输送到目标，在不到3分钟内破坏约2.5cm的区域。对药物/热损伤组合的研究还在组织模型中表现出改善的结果。第2阶段旨在1）验证和测试下一代内窥镜兼容冷冻导管，2）集成了一种新型原位可展开 - 多点热传感器，以使得能够真实的实时监测目标的热分布，消融，3）开发和评估一系列维生素D3类似物（商业和新型），并测试在离体工程肿瘤模型和体内工程肿瘤模型中的最佳组合装置和类似物方案问题研究该项目建立在成功的P1研究以及其他研究的基础上，来自CPSI、渥太华大学、宾厄姆顿大学和约翰霍普金斯大学的研究人员的专业知识医学院开发一种新的手术器械和预防性药物组合方法，更有效地治疗肝癌和胰腺癌。一旦完成，该项目将提供一个有效的，微创治疗选择的个人患有这些和其他基于胃肠的癌症，如结肠直肠癌、胃癌和食道癌。成功该项目的完成将提供一种新型医疗器械，应用先进的个性化治疗方案，从许多胃肠道组织疾病状态，这些疾病状态是不可治疗的或治疗不充分的，当今最先进的器械可提高患者的生存率和生活质量。