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.

项目总结/摘要 食管癌是一种侵袭性疾病，五年生存率低于20%。的发生率 在过去的50年里，这种癌症急剧增加，预计至少在2010年前， 2030.慢性酸反流导致食管内层的变化和巴雷特的发展 部分患者出现食管炎。Barrett食管（BE）患者的风险增加了50倍， 与普通人群相比，癌症的发生率更高。 在过去的二十年中，出现了几种内镜消融方法来治疗或预防食管癌。 癌目前所有消融技术仅限于在医院环境中使用。必须给病人注射镇静剂 而在输送消融装置之前内窥镜穿过口腔。经济负担 除了最晚期的癌前病症和癌症之外，所有的治疗都是禁止的。不便， 缺乏当地供应商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 中低收入国家。非洲黑人食管癌的发病率比非洲黑人高出两到三倍， 对他们的白色同伴。 最近，已经开发了多种新的诊断模式。这些选择中有几个是未使用镇静剂的 和办公室为基础，这可能会发现更多的病人，因为大多数人与BE去不明。 因此，开发新的治疗方法是至关重要的，这些方法将消除障碍，例如需要镇静， 医院通道、昂贵的内窥镜检查和消融系统，以及需要再处理和维修设备。 CryoScope Medical的专利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，从而实现无镇静剂冷冻消融。冷冻消融术的独特之处在于， 与广播相比，治疗对组织具有镇痛作用，并减少术后对麻醉剂的依赖 射频消融（RFA）。冷冻消融是FDA批准的食管消融。冷冻消融与 经鼻内窥镜将提供先进的治疗，在一个低成本，紧凑的设备，将使这种治疗 在资源匮乏的环境中，数百万人都可以使用。 在这个项目中，初步的设备开发将用于开发一个完整的功能原型，我们的 新型经鼻冷冻治疗装置。我们的方法包括利用经过验证的计算模型， 3D打印能够在关键的竞争约束条件下快速优化并收敛于最佳设计。项目 包括通过实验室测试以及医生评估研究进行验证。具体来说，行业领先 内窥镜医生将收到该装置的原型，以进行模拟手术来评估装置性能。 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，第一种用于低资源环境的冷冻消融设备将在 根据稳健的成功标准设计和验证，以降低全球食管癌的发病率。