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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginitis; Vaginal Infection
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Fung-Wei Chang; Phone Number: 12304 886-2-87923311; Email: doc30666@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 10449
    • Recruiting
    • Mackay Memorial Hospital
    • Contact: Dr. Wen-Chu Huang; Phone Number: 886-975835350; Email: wjhuang4438@yahoo.com.tw
    • Principal Investigator: Dr. Wen-Chu Huang
    • Sub-Investigator: Dr. Chia-Sui Weng
  • Taipei, Taiwan, 11490
    • Recruiting
    • TRI-Service General Hospital
    • Contact: Dr. Fung-Wei Chang; Phone Number: 12304 886-2-87923311; Email: doc30666@gmail.com
    • Principal Investigator: Dr. Fung-Wei Chang
    • Sub-Investigator: Dr. Chi-Kang Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Vaginal swab for RT-PCR; Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans; Device: Vaginal swab for culture; Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli; 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.; 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.
Experimental: Fungal infection : The subject is infected with Candida albicans only.	Device: Vaginal swab for RT-PCR; Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans; Device: Vaginal swab for culture; Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli; 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.; 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.
Experimental: Mixed infection; Bacterial and fungal infections coexist.	Device: Vaginal swab for RT-PCR; Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans; Device: Vaginal swab for culture; Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli; 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.; 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.
Experimental: No infection; Healthy participant	Device: Vaginal swab for RT-PCR; Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans; Device: Vaginal swab for culture; Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Taiwan Carbon Nano Technology Corporation
• Collaborators: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
• Investigators: Principal Investigator: Dr. Fung-Wei Chang, TRI-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: E-Nose
• Additional Relevant MeSH Terms: Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginitis; Vaginal Discharge
• Other Study ID Numbers: A202203003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No