RecruitingNot ApplicableNCT05557318

Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge


Sponsor

Taiwan Carbon Nano Technology Corporation

Enrollment

120 participants

Start Date

Oct 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 50 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DEVICEVaginal swab for RT-PCR

Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans

DEVICEVaginal swab for culture

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

DEVICEMetabolic gas signatures detected by Ainos Flora (operated by participant)

The participant operates the Ainos Flora to collect signatures of metabolic gases in the vagina by herself.

DEVICEMetabolic gas signatures detected by Ainos Flora (operated by medical staff)

The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.


Locations(2)

MacKay Memorial Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

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NCT05557318


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