An interventional study of Vaginal swab for RT-PCR and Vaginal swab for culture in Vaginal Infection and Vaginitis, sponsored by Taiwan Carbon Nano Technology Corporation. Recruiting at 2 sites in Taiwan. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Taiwan Carbon Nano Technology Corporation · Not applicable, Interventional, and Diagnostic
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's planned enrollment of 120 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →This is the only study on the registry with Taiwan Carbon Nano Technology Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women who meet any of the following criteria by participant report will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · 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)
The subject is infected with Candida albicans only.
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)
Bacterial and fungal infections coexist.
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)
Healthy participant
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)
Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans
Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli
The participant operates the Ainos Flora to collect signatures of metabolic gases in the vagina by herself.
The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Sep 2025, 35 months after the start.
Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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