CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting

描述(由申请人提供)：宫颈癌是低收入和中等收入国家(LMIC)的主要死亡原因。为了解决这一问题，世界卫生组织最近发布了指南，支持基于HPV的筛查和冰醋酸(VIA)目视检查。这些指导方针将有助于扩大宫颈癌“癌前病变”的筛查覆盖面和检测范围，“癌前病变”是一种可治愈的宫颈癌先兆。然而，筛查必须与及时和适当的治疗相联系，以降低死亡率。目前的治疗标准，以一氧化二氮(N2O)为基础的冷冻治疗，由于昂贵、难以获得和难以运输，未能充分解决这一问题。该应用的目的是将非气体消融设备CryoPen(R)冷冻外科系统转变为一种廉价且易于运输的冷冻治疗设备，专门用于可供任何级别的医疗保健提供者使用的LMIC中。该项目的具体目标是：1.开发一种适用于LMIC的CryoPen(R)冷冻外科系统，该系统针对LMIC的使用进行了优化。2.表明LMIC适应的CryoPen(R)具有临床应用潜力。3.证明CryoPen(R)治疗宫颈癌前病变的治愈率不逊于基于N2O的冷冻疗法。4.创建适用于LMIC的CryoPen(R)的部署和使用的全面模式。一种可运输、可靠和廉价的设备的开发将改变宫颈癌预防范例，从“看一看”的策略转变为一种真正的“看一看、看一看”的综合现场治疗方法。将采取的行动步骤是将目前的CryoPen(R)修改为适合LMIC的版本：通过执行非劣质的坏死深度测试来确保临床潜力，然后完成具有成本效益的临床试验 分析。预期的结果是开发出一种非劣质、更具成本效益、更适合LIMC环境的疗法，而不是基于N2O的冷冻疗法。我们的研究团队与领先的地区性组织建立了良好的关系，这些组织为政府运营的宫颈癌预防项目提供指导。在这些已经存在的项目中引入CryoPen(注册商标)不仅将提高项目效率，还将成为该地区采用该技术的典范。这项研究的结果将影响其他研究领域，作为一个跳板，探索可在全球范围内用于低收入中等收入国家，从而惠及最脆弱人群的治疗替代方案。

DESCRIPTION (provided by applicant): Cervical cancer is a leading cause of mortality in low and middle-income countries (LMICs). In order to address this problem, the World Health Organization has recently released guidelines that endorse HPV based screening and visual inspection with acetic acid (VIA). These guidelines will facilitate increased screening coverage and detection of cervical "precancer", a curable precursor to cervical cancer. However, screening must be linked to timely and adequate treatment in order to decrease mortality. The current treatment standard, nitrous oxide (N2O) based cryotherapy, has failed to adequately address the problem as it is expensive, difficult to procure, and hard to transport. The purpose of this application is to transform a non-gas based ablative device, the CryoPen(R) Cryosurgical System, into an inexpensive and easily transportable cryotherapy device, specifically for use in LMICs that can be used by any level of health care provider. The Specific Aims of this project are to 1. Develop an LMIC-adapted CryoPen(R) Cryosurgical System that is optimized for use in LMICs. 2. Show that the LMIC-adapted CryoPen(R) has clinical potential. 3. Demonstrate that the cure rate of CryoPen(R) is non-inferior to N2O-based cryotherapy for the treatment of cervical precancer. 4. To create a comprehensive model for the deployment and use of the LMIC-adapted CryoPen(R). Development of a transportable, reliable, and inexpensive device will change the cervical cancer prevention paradigm from a "see and refer" strategy to an integrated true "see and treat" field approach. The action steps that will be taken to modify the current CryoPen(R) to an LMIC-adapted version are: ensuring clinical potential by performing a non-inferiority depth of necrosis test and then completing a clinical trial with cost effectiveness analysis. The expected results are the development of a treatment that is non-inferior, more cost-effective, and better suited to the LIMC setting than N2O-based cryotherapy. Our research team has well established relationships with leading regional organizations that provide guidance to government run cervical cancer prevention programs. Introduction of the CryoPen(R) to these already existing programs will not only improve program efficacy, but will also serve as a model for adoption of the technology in the region. The results of this study will affect other research areas by serving as a springboard to explore treatment alternatives that can be used globally in LMICs and thus reach the most vulnerable populations.