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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治疗多种疾病状态的策略。同时提供了一条很有希望的途径革命性的医学，个性化，微创，组合疗法的发展由于技术的限制而变慢了。因此，迫切需要设计促进改变范式的新设备的开发，最小限度地侵袭，方法就地治疗病变组织，从而能够采取跨学科的策略与疾病作斗争。这一阶段建立在已完成的第一阶段成功的基础上的2个项目就是为了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 (冻伤)用于治疗各种胃肠道癌症，包括胰腺癌和肝癌。这一多功能平台将使多种治疗和诊断的应用成为可能单一设备格式的方法(药物、消融等)，当组合在一起时新型维生素D3类似物旨在增加冷冻的致命性，将提供增强了多种癌症的治疗选择。提供多参数治疗的能力通过加入一种新型的可展开的导管来改进冻伤导管的治疗方案用于实时监测消融区形成的温度传感器。这一点与先进的成像方法的兼容性，包括内窥镜超声、核磁共振和CT，将提供在一个过程中无与伦比的控制和可视化。第一阶段的活动产生了1.27 mm的原型针尖导管能够在10秒内将低温损伤传递到目标，从而产生在不到3分钟的时间里破坏了~2.5厘米的区域。联合用药/热损伤的研究在组织模型中证明了改善的结果。此阶段2旨在1)小型化和测试下一代内窥镜兼容低温测量仪，2)集成了一种新型的可原位展开的多点热传感器，能够实时监测目标的热轮廓消融，3)开发和评估一系列维生素D3类似物(商业和新型)，并测试体外和体内工程肿瘤模型中的最佳组合装置和模拟方案学习。该项目建立在成功的P1研究以及其他研究的基础上，并利用 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将开发一种新的手术器械和辅助药物组合方法更有效地治疗肝癌和胰腺癌。一旦完成，该项目将提供对于患有这些和其他疾病的个人来说，一种有效的微创治疗选择以胃肠病为基础的癌症，如结直肠癌、胃癌和食道癌。成功该项目的完成将提供一种新的医疗设备，使开发和应用先进的个体化治疗方案治疗上千例S患者从许多无法治疗或治疗不充分的胃肠道组织疾病状态当今最先进的设备提高了患者的存活率和生活质量。