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

CryoPen：资源匮乏环境下宫颈癌前病变的创新治疗方法

• 批准号: 8930106
• 负责人: Miriam Cremer
• 金额: $ 48.72万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-14 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930106
• 关键词: Ablation; Acetic Acids; Address; Adoption; Affect; Aftercare; Area; Ballistics; Biomedical Engineering; Businesses; Care Technology Points; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Clinical; Clinical Trials; Cold Therapy; Colombia; Cost Effectiveness Analysis; Country; Cytology; DNA; Data; Detection; Development; Devices; Diagnostic tests; Economic Models; Electricity; Ensure; Evaluation; Freezing; Gelatin; Government; Guidelines; Health; Health Personnel; Health Status; Human Papillomavirus; Hysterectomy; Income; Lead; Lesion; Life; Link; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical; Methods; Modality; Modeling; National Cancer Institute; Necrosis; Nitrous Oxide; Peru; Premalignant; Prevention program; Property; Public Health; Randomized; Recommendation; Refit; Research; Research Personnel; Residual state; Resources; Running; Source; Specimen; Surface; System; Technology; Temperature; Testing; Therapeutic; Tissues; Training; Visual; Vulnerable Populations; Woman; Work; World Health Organization; alternative treatment; base; cervical cancer prevention; cost; cost effective; cost effectiveness; effective therapy; improved; innovation; mortality; novel; portability; programs; prototype; public health relevance; screening; standard care

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.

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。为了解决这个问题，世界卫生组织最近发布了支持基于HPV的筛查和醋酸（VIA）目视检查的指南。这些准则将有助于扩大筛查覆盖面和检测宫颈“癌前期”，这是宫颈癌的一种可治愈的前兆。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，因为它是昂贵的，难以采购，难以运输。本申请的目的是将非气体基消融设备CryoPen（R）冷冻外科系统转换成廉价且易于运输的冷冻治疗设备，特别是用于可由任何级别的医疗保健提供者使用的LMIC。该项目的具体目标是1。开发一种适用于LMIC的CryoPen（R）冷冻手术系统，该系统针对LMIC的使用进行了优化。2.证明适应LMIC的CryoPen（R）具有临床潜力。3.证明CryoPen（R）治疗宫颈癌前病变的治愈率不劣于基于N2O的冷冻疗法。4.为部署和使用适用于LMIC的CryoPen（R）创建综合模型。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“看和参考”战略转变为综合的真正的“看和治疗”现场方法。将当前CryoPen（R）修改为LMIC适应版本所采取的行动步骤是：通过执行非劣效性坏死深度测试确保临床潜力，然后完成具有成本效益的临床试验 分析.预期的结果是开发一种非劣效、更具成本效益且比基于N2O的冷冻疗法更适合LMC环境的治疗方法。我们的研究团队与领先的区域组织建立了良好的关系，这些组织为政府管理的宫颈癌预防计划提供指导。将CryoPen（R）引入这些现有项目不仅可以提高项目效率，还可以作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中低收入国家的治疗替代方案，从而达到最脆弱的人群。