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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05557318
Other study ID # A202203003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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