Vaginitis Clinical Trial
Official title:
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - Female, Age =20 to =50. - Have had sexual experience. - Fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | MacKay Memorial Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taiwan Carbon Nano Technology Corporation | Ainos, Inc. (f/k/a Amarillo Biosciences Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis. | 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 |
Up to 6 months. | |
Secondary | Assess the change in sensitivity as the number of subjects is changed. | When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the sensitivity. We can then assess the change in sensitivity when the number of subjects changes from 30 to 60, 90, and 120. | Up to 6 months. | |
Secondary | Assess the change in specificity as the number of subjects is changed. | When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the specificity. We can then assess the change in specificity when the number of subjects changes from 30 to 60, 90, and 120. | Up to 6 months. |
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