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

Taiwan Carbon Nano Technology

Status: Enrolling

Conditions: Vaginitis; Vaginal Infection

Treatments: Device: Metabolic gas signatures detected by Ainos Flora (operated by participant); Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff); Device: Vaginal swab for RT-PCR; Device: Vaginal swab for culture

Study type: Interventional

Funder types: Industry

Identifiers

NCT05557318

A202203003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Bacterial infections

Experimental group

Description:

The subject is infected with at least one of the following pathogens: Bacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhoeae

Treatment:

Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)

Device: Vaginal swab for culture

Device: Vaginal swab for RT-PCR

Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)

Fungal infection :

Experimental group

Description:

The subject is infected with Candida albicans only.

Treatment:

Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)

Device: Vaginal swab for culture

Device: Vaginal swab for RT-PCR

Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)

Mixed infection

Experimental group

Description:

Bacterial and fungal infections coexist.

Treatment:

Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)

Device: Vaginal swab for culture

Device: Vaginal swab for RT-PCR

Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)

No infection

Experimental group

Description:

Healthy participant

Treatment:

Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)

Device: Vaginal swab for culture

Device: Vaginal swab for RT-PCR

Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)