Low-Cost, Single-Use Trans-Nasal Cryotherapy Device for Low-Resource Settings

适用于资源匮乏环境的低成本、一次性经鼻冷冻治疗设备

基本信息

批准号：
10761295
负责人：
Jason H Rahimzadeh
金额：
$ 40.65万
依托单位：
CRYOSCOPE MEDICAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-26 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10761295
关键词：
3D Print Ablation Address Adverse event African Analgesics Barrett Esophagus Boston Capital Cardiovascular system Catheters Chronic Clinical Cold Therapy Computer Models Cost Analysis Cryosurgery Development Device or Instrument Development Devices Diameter Disease Dose Economic Burden Elderly Endoscopes Endoscopy Engineering Equipment Esophageal Diseases Esophagus Evaluation Evaluation Studies FDA approved Family suidae Gases Gastroesophageal reflux disease General Population Grant Head Health Services Accessibility High-Cost Technology Hospitals Incidence Industry Laws Legal patent Letters Liquid substance Malignant Neoplasms Malignant neoplasm of esophagus Medical Methods Minority Modality Narcotics Nature Nitrogen Nose Obesity Optics Oral cavity Outcome Pain Patients Perforation Performance Persons Phase Physicians Precancerous Conditions Procedures Process Protocols documentation Provider Radiofrequency Interstitial Ablation Reporting Resistance Resolution Resource-limited setting Risk Risk Factors Scientist Sedation procedure Survival Rate System Technology Testing Therapeutic Tissues Torque Training Validation Visualization comorbidity cost cryogenics design dosimetry effective therapy experience fabrication first-in-human improved in silico infection risk innovation low and middle-income countries medically underserved novel novel diagnostics novel therapeutics premalignant prevent product development prototype repaired research clinical testing success therapeutically effective tool underserved community

项目摘要

PROJECT SUMMARY/ABSTRACT Esophageal cancer is an aggressive disease with a five-year survival rate below 20 percent. The incidence of this cancer has increased dramatically over the last 50 years and is projected to continue increasing at least until 2030. Chronic acid reflux leads to changes in the lining of the esophagus and the development of Barrett’s Esophagus in some patients. Patients with Barrett’s esophagus (BE) have a 50-fold increase in their risk of developing cancer compared to the general population. Over the last two decades, several endoscopic ablation methods have emerged to treat or prevent esophageal cancer. All current ablation technologies are limited to use in the hospital setting. Patients must be sedated while an endoscope is passed through the mouth before the ablation device is delivered. The economic burden of therapy can be prohibitive for all but the most advanced pre-cancerous conditions and cancer. Inconvenience, lack of local providers, and pain are also barriers to wider acceptance, especially in low- and middle-income countries (LMICs). The incidence of esophageal cancer is two to three times higher in black Africans compared to their white counterparts. More recently, multiple new diagnostic modalities have been developed. Several of these options are unsedated and office-based, which will likely identify many more patients since most people with BE go unidentified. Accordingly, it is critical to develop new therapies which would eliminate barriers such as the need for sedation, hospital access, costly endoscopy and ablation systems, and the need to reprocess and repair equipment. CryoScope Medical’s patented single-use ablation device is the first and only device that allows the physician to trans-nasally pass into the esophagus, enabling unsedated cryoablation. Cryoablation is unique in that the therapy has an analgesic effect on tissues and reduces reliance on narcotics post-procedure, compared to Radio Frequency Ablation (RFA). Cryoablation is FDA-approved for esophageal ablation. Combining cyroablation with trans-nasal endoscopy will provide advanced treatment in a low-cost, compact device that will make this therapy accessible to millions of people in low-resource settings. In this project, preliminary device development will be used to develop a complete functional prototype of our novel trans-nasal cryotherapy device. Our approach includes leveraging a validated computational model and 3D printing to rapidly iterate and converge on an optimal design within the key competing constraints. The project involves verification by benchtop testing as well as a physician evaluation study. Specifically, industry-leading endoscopists will receive a prototype of the device to conduct a mock procedure to assess device performance. Iterative development based on the physician evaluation study will guide further improvements to the prototype. Ultimately, as a result of this project, a first-of-its-kind cryoablation device for low-resource settings will be designed and validated against robust success criteria to mitigate the global incidence of esophageal cancer.

项目概要/摘要食管癌是一种侵袭性疾病，五年生存率低于 20%。这种癌症在过去 50 年里急剧增加，预计至少会持续增加到 2030. 慢性胃酸反流导致食道内壁变化和巴雷特氏病的发展一些患有巴雷特食管 (BE) 的患者患食管的风险增加了 50 倍。与一般人群相比，罹患癌症。在过去的二十年中，出现了几种内窥镜消融方法来治疗或预防食管癌目前所有的消融技术都仅限于在医院环境中使用，患者必须服用镇静剂。而内窥镜在消融装置送达之前要经过口腔，造成经济负担。除了最晚期的癌前病变和癌症之外，治疗的效果可能令人望而却步，缺乏当地提供者和痛苦也是更广泛接受的障碍，特别是在低收入和中等收入国家非洲黑人的食道癌发病率是中低收入国家的两到三倍。给他们的白人盟友。最近，已经开发出多种新的诊断方式，其中一些选择是非镇静的。以及基于办公室的，这可能会识别出更多的患者，因为大多数 BE 患者的身份都未被识别。因此，开发新的疗法来消除诸如镇静需求等障碍至关重要。医院通道、昂贵的内窥镜和消融系统以及重新处理和修理设备的需要。 CryoScope Medical 获得专利的一次性消融设备是第一个也是唯一一个允许医生经鼻进入食道，实现无镇静冷冻消融术的独特之处在于与放射疗法相比，该疗法对组织具有镇痛作用，并减少了术后对麻醉剂的依赖冷冻消融 (RFA) 已获得 FDA 批准，可与冷冻消融结合使用。经鼻内窥镜将以低成本、紧凑的设备提供先进的治疗，这将使这种疗法资源匮乏地区的数百万人可以使用。在这个项目中，初步的设备开发将用于开发我们的完整功能原型我们的方法包括利用经过验证的计算模型和 3D 打印可在关键竞争限制内快速迭代并收敛到最佳设计。涉及通过台式测试以及医生评估研究进行验证，具体而言，是行业领先的。内窥镜医师将收到该设备的原型，以进行模拟程序来评估设备性能。基于医生评估研究的迭代开发将指导原型的进一步改进。最终，作为该项目的结果，第一个用于资源匮乏环境的冷冻消融设备将被问世。根据严格的成功标准进行设计和验证，以降低全球食管癌的发病率。