To evaluate a low –cost efficient and effective Enhanced Visual Assessment System developed by Mobile ODT on the basis of ease of use, affordability, increased revenue to offset cost and patient / provider satisfaction.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Patients detected with cervical cancer / precancerous reasons
研究概览
简要总结
This study is a non randomized, observational screening study to detect cervical cancer using the low cost and effective Enhanced Visual Assesment System (EVA System) developed by Mobile ODT.
- This system is a low cost system comprised of 3 elements –
- The scope which is Mobile, lightweight, and durable medical device for magnified inspection that includes an ultra-bright light source with glare-reducing cross-polarization technology, a lens enabling up to 17 times magnification for superior imaging, and a rechargeable battery for up to 10 hours of continuous examinations.
- The app- Mobile phone based application allowing confidential data capture and review, remote expert decision support and patient engagement through image review.
- The Portal: An online quality control, measurement and evaluation system facilitating screening, consultation, and program level analytic review from anywhere in the world.
The system is attempting to better the gold standard of PAP smear by introducing digital cervicography an advanced cervical cancer screening method, into primary screening, thus exploring the technology’s ability to reduce loss to follow up and provide easy care diagnosis.
A sample size of 1500-2000 patients will be taken during this study. During the study, using the EVA system, the patients detected with cervical cancer / precancerous conditions will be measured as will the patients detected with cervical cancer / precancerous conditions having negative initial screening results (PAP smear / HPV are –ve) will be measured.
The provider and patient satisfaction will also be measured.
There are numerous studies attempting to better the cervical cancer screening with regards to better sensitivity and specificity. If found to be successful, this study will help us significantly raise the standards of cervical screening
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Able to understand and consent to participating in the study.
排除标准
- •Women previously detected with cervical cancer.
结局指标
主要结局
Patients detected with cervical cancer / precancerous reasons
时间窗: 6 months
次要结局
- Provider and patient satisfaction with EVA System, consistent with utilization of the device(6 months)