Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.
研究概览
简要总结
This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.
详细描述
Ainos Flora Women's Vaginal Health Tester is an in vitro diagnostic device implementing electronic nose technology to detect vaginal infections by examining metabolized gases of vaginal bacteria. The electronic nose system mainly comprises the Micro-Electro-Mechanical Systems (MEMS) gas sensor array and the Artificial Neural Network algorithm. The primary purpose of this study is to train the algorithm and assess the performance of the Ainos Flora in identifying vaginal infections. In addition, the primary outcome measures of this study, including sensitivity and specificity, will be used as a reference for the feasibility and sample size assessment of the next phase of pivotal clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, Age ≥20 to ≤
- •Have had sexual experience.
- •Fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures.
排除标准
- •Women who meet any of the following criteria by participant report will be excluded from the study:
- •During menstruation.
- •Have performed vaginal washing within three days.
- •Have been treated for vaginal infections within one week.
结局指标
主要结局
To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.
时间窗: Up to 6 months.
* Bacterial infection : Bacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhea * Fungal infection: Candida albicans * Mixed infection: Bacterial and fungal infections coexist * No infection: Healthy participant
次要结局
- Assess the change in specificity as the number of subjects is changed.(Up to 6 months.)
- Assess the change in sensitivity as the number of subjects is changed.(Up to 6 months.)