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

Vaginitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557318
• Other study ID #: A202203003
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Taiwan Carbon Nano Technology Corporation
• Contact: Dr. Fung-Wei Chang
• Phone: 886-2-87923311
• Email: doc30666[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Discharge
• Vaginal Infection
• Vaginitis

Intervention

Device:
• Vaginal swab for RT-PCR
Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans
• Vaginal swab for culture
Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli
• 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.
• 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

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taiwan Carbon Nano Technology Corporation	Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 months.
Secondary	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.	Up to 6 months.
Secondary	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.	Up to 6 months.