Development, field testing and evaluation of the efficacy of a hand-held, portable and affordable thermo-coagulator to prevent cervical cancer in low- and middle-income countries

开发、现场测试和评估手持式、便携式和负担得起的热凝固器在低收入和中等收入国家预防宫颈癌的功效

• 批准号: 10323696
• 负责人: Partha Basu
• 金额: $ 35万
• 依托单位: INTERNATIONAL AGENCY FOR RES ON CANCER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-07 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323696
• 关键词: Acetic Acids; Africa South of the Sahara; Carbon Dioxide; Cervical; Coagulation Process; Collaborations; Colposcopy; Development; Devices; Disadvantaged; Engineering; Excision; Failure; Gases; Hand; In Vitro; Laboratories; Malignant neoplasm of cervix uteri; Medical; Medical Device; Methods; Modeling; Normalcy; Performance; Randomized; Randomized Controlled Trials; Scanning; Testing; Time; Utah; Visual; Woman; Zambia; arm; base; compare effectiveness; cost; efficacy evaluation; field study; histopathological examination; improved; in vivo; light weight; low and middle-income countries; novel; overtreatment; portability; prevent; programs; public health relevance; satisfaction; screening program; standard care; success; trial comparing; user-friendly

 DESCRIPTION (provided by applicant): Successful cervical precancer screening programmes have not been replicated widely in Low and Middle Income Countries (LMICs) for a variety of reasons but largely due to the expense of laboratory based tests and colposcopy. Instead screen and treat programmes have been established relatively widely. These programmes are not trouble or cost free but are relatively inexpensive and successful. The most commonly used combination is Visual Inspection with Acetic acid (VIA) to screen and cryocautery to treat. Both of these have disadvantages. VIA overcalls abnormality relatively frequently and cryocautery is fraught with difficulties in gas (CO2 or N2O) supply both because it is variably expensive, variably available and difficult to transport. Furthermore the long treatment time of cryocautery (11minutes in total) is perceived as a relative problem compared to Thermal Coagulation (1 - 2 mins) or LLETZ (1-2 minutes). Aims : This project aims to improve screen and treat programmes by discovering the best method of treatment and by reducing the treatment of normal women. The specific aims are 1. To develop, test and produce 200 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah). 2. To evaluate the success / failure rate of Thermal Coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to Large Loop Excision of the Transformation Zone (LLETZ aka LEEP) as part of a screen and treat programme in Zambia. 3. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia. 4. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases. 5. To determine the value of Z scan to predict normality and abnormality in VIA positive women randomly assigned to excisional therapy Methods : In collaboration with a medical devices company in Utah, we will develop and test the engineering performance of the Liger Thermal Coagulator in vitro and in vivo. We will produce 200+ Liger units and undertake a randomised controlled trial of the device compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy will allow us to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women

 描述（由申请人提供）：由于多种原因，成功的宫颈癌前筛查计划尚未在低收入和中等收入国家 (LMIC) 广泛推广，但主要是由于基于实验室的测试和阴道镜检查的费用。相反，筛查和治疗计划已经相对广泛地建立起来。这些计划并非没有麻烦或没有成本，但相对便宜且成功。最常用的组合是目视检查、醋酸 (VIA) 筛查和冷冻治疗。这两者都有缺点。 VIA 相对频繁地报告异常情况，而冷冻烧灼术在气体（CO2 或 N2O）供应方面充满困难，因为其价格不一、可用性不一且难以运输。此外，与热凝固（1-2 分钟）或 LLETZ（1-2 分钟）相比，冷冻烧灼治疗时间长（总共 11 分钟）被认为是一个相对问题。目标：该项目旨在通过发现最佳治疗方法和减少对正常女性的治疗来改进筛查和治疗方案。具体目标是 1. 开发、测试和生产 200 种新型轻型手持式无线、便携式电池驱动和可充电热凝固器（Liger Medical，犹他州）。 2. 在一项随机对照试验中评估热凝固的成功/失败率，该试验将热凝固与现有标准冷冻治疗和转化区大环切除术（LLETZ 又名 LEEP）进行比较，作为赞比亚筛查和治疗计划的一部分。 3. 作为赞比亚筛选和治疗计划的一部分，评估 Liger 热凝固器冷冻治疗的用户满意度评分。 4. 通过对随机分配的切除治疗病例进行组织病理学检查，确定 VIA 阳性女性的过度治疗率。 5. 确定 Z 扫描对随机分配接受切除治疗的 VIA 阳性女性预测正常和异常的价值 方法：与犹他州的一家医疗器械公司合作，我们将开发并测试 Liger 热凝固器的体外和体内工程性能。我们将生产 200 多个 Liger 装置，并以功效和用户友好性作为终点，对该设备与冷冻烧灼和 LLETZ 进行比较进行随机对照试验。纳入切除治疗研究组将使我们能够量化 VIA 计划中的过度治疗率，并且使用 Z 扫描可能会提供一种非侵入性方法，准确预测 VIA 阳性女性的正常和异常情况