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RECRUITING
NCT05557318
NA

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

Sponsor: Taiwan Carbon Nano Technology Corporation

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-10-08

Completion Date

2025-10

Last Updated

2024-04-10

Healthy Volunteers

Yes

Interventions

DEVICE

Vaginal swab for RT-PCR

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

DEVICE

Vaginal swab for culture

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

DEVICE

Metabolic 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.

DEVICE

Metabolic 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