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

• 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
• 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

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.

项目摘要/摘要 食管癌是一种侵略性疾病，生存率低于20％。事件 在过去的50年中，这种癌症急剧增加，预计至少要继续增加 2030年。慢性酸会导致食道壁和巴雷特的发展变化 一些患者的食道。巴雷特食管（BE）患者的风险增加了50倍 与普通人群相比，发展癌症。 在过去的二十年中，已经出现了几种内窥镜消融方法来治疗或预防食管 癌症。所有当前的消融技术都仅限于医院环境中。必须镇静患者 当烧蚀装置传递之前，内窥镜通过口径通过嘴。经济伯恩 除了最先进的癌前状况和癌症以外，可以禁止所有治疗。不便， 缺乏本地提供者，疼痛也是广泛接受的障碍，尤其是在低收入和中等收入中 国家（LMIC）。与黑人非洲人相比，食管癌的事件高两到三倍 与他们的白人同行。 最近，已经开发了多种新的诊断方式。这些选项中有几个是未经规定的 和基于办公室的人，这可能会发现更多的患者，因为大多数患者都不确定。 彼此之间，开发新的疗法至关重要 医院通道，昂贵的内窥镜和消融系统，以及重新处理和维修设备的需求。 Cryoscope Medical的专利单利消融设备是允许物理学的第一个也是唯一的设备 跨鼻腔进入食道，实现了未婚的冷冻化。冷冻化是独一无二的 与无线电相比 频率消融（RFA）。冷冻化是FDA批准的，用于食管消融。结合Cyroablation 跨鼻腔内窥镜检查将在低成本，紧凑的装置中提供高级治疗，这将使这种疗法 在低资源环境中，数百万的人可以访问。 在这个项目中，初步设备开发将用于开发我们的完整功能原型 新型的跨鼻冷冻疗法。我们的方法包括利用经过验证的计算模型和 3D打印以迅速迭代并收敛于关键竞争限制内的最佳设计。项目 涉及通过台式测试以及物理评估研究进行验证。具体而言，行业领先 内窥镜医生将收到设备的原型，以进行模拟程序来评估设备性能。 基于物理评估研究的迭代发展将指导原型的进一步改进。 最终，由于这个项目，低资源设置的首次使用冷冻设备将是 设计和验证了符合强大的成功标准，以减轻全球食管癌的事件。