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

 描述（由申请人提供）：由于各种原因，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，但主要是由于实验室检测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。这些方案并非没有麻烦或费用，但相对便宜和成功。最常用的组合是用乙酸（VIA）进行目视检查以筛选和冷冻烧灼治疗。这两种方法都有缺点。VIA相对频繁地忽略异常，并且低温烧灼术在气体（CO2或N2 O）供应方面充满困难，因为它非常昂贵，难以获得并且难以运输。此外，与热凝固（1 - 2分钟）或LLETZ（1-2分钟）相比，冷冻烧灼术的治疗时间较长（总计11分钟）被视为一个相对问题。目的：该项目旨在通过发现最佳治疗方法和减少对正常妇女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台新型轻型手持式无绳、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价热凝固的成功/失败率，该试验将热凝固与现有标准冷冻烧灼术和转化区大环切除术（LLETZ aka LEEP）进行比较，作为赞比亚筛查和治疗计划的一部分。 3.评价Liger热凝器冷冻烧灼术的用户满意度评分，作为赞比亚筛查和治疗项目的一部分。 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扫描预测随机分配到切除治疗的VIA阳性女性的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，我们将在体外和体内开发和测试Liger热凝固器的工程性能。我们将生产200多个Liger装置，并进行一项随机对照试验，将该器械与冷冻烧灼术和LLETZ进行比较，使用疗效和用户友好性作为终点。纳入切除治疗的研究臂将使我们能够量化VIA程序中过度治疗的比率，并且使用Z扫描可以允许准确预测VIA阳性女性的正常和异常的非侵入性方法

 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