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（LMICs）的主要死亡原因。为了解决这个问题，世界卫生组织最近发布了指导方针，支持基于HPV的筛查和醋酸目视检查（VIA）。这些指导方针将有助于增加子宫颈“癌前病变”的筛查覆盖率和检测，这是一种可治愈的子宫颈癌前兆。然而，筛查必须与及时和充分的治疗联系起来，以降低死亡率。目前的治疗标准，基于一氧化二氮（N2O）的冷冻疗法，未能充分解决这个问题，因为它昂贵，难以采购，难以运输。本应用的目的是将CryoPen(R)冷冻手术系统（一种非气体基烧蚀设备）转变为一种廉价且易于运输的冷冻治疗设备，专门用于低收入国家，可由任何级别的医疗保健提供者使用。该项目的具体目标是：1。开发适合lmic的CryoPen(R)冷冻手术系统，该系统针对lmic进行了优化。2. 表明适应lmic的CryoPen(R)具有临床潜力。3. 表明CryoPen(R)的治愈率不低于基于n2o的冷冻治疗宫颈癌前病变。4. 为部署和使用适应lmic的CryoPen(R)创建一个综合模型。开发一种可运输、可靠和廉价的设备将改变宫颈癌预防模式，从“看和转诊”策略转变为真正的综合“看和治疗”现场方法。将目前的CryoPen(R)修改为lmic适应版本将采取的行动步骤是：通过进行非劣效性坏死深度试验来确保临床潜力，然后完成具有成本效益的临床试验

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.