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

 说明(申请人提供)：由于各种原因，成功的宫颈癌前筛查方案没有在低收入和中等收入国家广泛推广，但主要是因为实验室检测和阴道镜检查的费用。相反，筛查和治疗方案已经建立得相对广泛。这些项目不是没有麻烦，也不是没有成本，但相对便宜和成功。最常用的组合是用醋酸目视检查(VIA)筛查和冷冻治疗。这两种做法都有缺点。VIA超标异常相对频繁，低温冷凝器在气体(CO2或N2O)供应方面充满困难，因为它的价格变化不定，可获得性不定，运输困难。此外，与热凝(1-2分钟)或LLETZ(1-2分钟)相比，冷冻治疗时间较长(总共11分钟)被认为是一个相对的问题。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种新型轻便手持式无线、便携式电池驱动和可充电的热凝固器(犹他州利格医疗公司)。2.作为赞比亚筛查和治疗方案的一部分，在一项随机对照试验中评估热凝治疗的成功/失败率，该试验将热凝治疗与现有的标准冷冻治疗和大环切除变形区(LLETZ又名LEEP)进行比较。3.作为赞比亚筛查和治疗方案的一部分，评估Liger热凝固器冷冻治疗的用户满意度分数。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阳性妇女的过度治疗率。5.确定Z扫描对随机分配到切除治疗的VIA阳性妇女的正常和异常的预测价值。方法：我们将与犹他州的一家医疗器械公司合作，开发和测试Liger热凝器的体外和体内工程性能。我们将生产200多个Liger设备，并以疗效和用户友好性为终点，对该设备与低温治疗和LLETZ进行随机对照试验。纳入切除治疗的研究分支将使我们能够量化VIA计划中过度治疗的比率，使用Z扫描可能允许使用非侵入性方法准确预测VIA阳性妇女的正常和异常

 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