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

Not Applicable

Recruiting

• Conditions: Vaginal Infection; Vaginitis
• Interventions: Device: Vaginal swab for RT-PCR; Device: Vaginal swab for culture; Device: Metabolic gas signatures detected by Ainos Flora (operated by participant); Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)

• Registration Number: NCT05557318
• Lead Sponsor: Taiwan Carbon Nano Technology Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2022-10-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fungal infection :	Vaginal swab for culture	The subject is infected with Candida albicans only.
Mixed infection	Vaginal swab for culture	Bacterial and fungal infections coexist.
Mixed infection	Metabolic gas signatures detected by Ainos Flora (operated by participant)	Bacterial and fungal infections coexist.
No infection	Vaginal swab for RT-PCR	Healthy participant
No infection	Metabolic gas signatures detected by Ainos Flora (operated by participant)	Healthy participant
Bacterial infections	Vaginal swab for culture	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
Bacterial infections	Metabolic gas signatures detected by Ainos Flora (operated by medical staff)	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
Mixed infection	Vaginal swab for RT-PCR	Bacterial and fungal infections coexist.
Bacterial infections	Vaginal swab for RT-PCR	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
Fungal infection :	Vaginal swab for RT-PCR	The subject is infected with Candida albicans only.
Fungal infection :	Metabolic gas signatures detected by Ainos Flora (operated by participant)	The subject is infected with Candida albicans only.
Fungal infection :	Metabolic gas signatures detected by Ainos Flora (operated by medical staff)	The subject is infected with Candida albicans only.
Mixed infection	Metabolic gas signatures detected by Ainos Flora (operated by medical staff)	Bacterial and fungal infections coexist.
No infection	Vaginal swab for culture	Healthy participant
No infection	Metabolic gas signatures detected by Ainos Flora (operated by medical staff)	Healthy participant
Bacterial infections	Metabolic gas signatures detected by Ainos Flora (operated by participant)	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

Primary Outcome Measures

Name	Time	Method
To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.	Up to 6 months.	* 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

Secondary Outcome Measures

Name	Time	Method
Assess the change in specificity as the number of subjects is changed.	Up to 6 months.	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.
Assess the change in sensitivity as the number of subjects is changed.	Up to 6 months.	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.

Trial Locations

Locations (2)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan