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

Taiwan Carbon Nano Technology Corporation120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Vaginal Infection Vaginitis

Interventions

Vaginal swab for RT-PCRDEVICE

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

Vaginal swab for cultureDEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

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

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Up to 6 months.

Secondary Outcomes

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.

Time frame: Up to 6 months.

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.

Time frame: Up to 6 months.

Central Contacts

Dr. Fung-Wei Chang

CONTACT

886-2-87923311 doc30666@gmail.com

Data from ClinicalTrials.gov

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