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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginal Infection Vaginitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This clinical study is a prospective study to evaluate the sensitivity and specificity of the Ainos Flora Female Vaginal Health Tester in identifying vaginal infections. Potential subjects will be patients in the gynecological clinic. The study will evaluate the performance of the Ainos Flora Female Vaginal Health Tester by comparing it to the conventional real-time polymerase chain reaction (RT-PCR) and culture methods for the diagnosis of vaginitis to calculate both sensitivity and specificity.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Bacterial infections

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

Group Type EXPERIMENTAL

Vaginal swab for RT-PCR

Intervention Type DEVICE

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

Vaginal swab for culture

Intervention Type DEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Fungal infection :

The subject is infected with Candida albicans only.

Group Type EXPERIMENTAL

Vaginal swab for RT-PCR

Intervention Type DEVICE

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

Vaginal swab for culture

Intervention Type DEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Mixed infection

Bacterial and fungal infections coexist.

Group Type EXPERIMENTAL

Vaginal swab for RT-PCR

Intervention Type DEVICE

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

Vaginal swab for culture

Intervention Type DEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

No infection

Healthy participant

Group Type EXPERIMENTAL

Vaginal swab for RT-PCR

Intervention Type DEVICE

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

Vaginal swab for culture

Intervention Type DEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Interventions

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Vaginal swab for RT-PCR

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

Intervention Type DEVICE

Vaginal swab for culture

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes