Vaginal InfectionNCT05557318
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
A study testing Vaginal swab for RT-PCR, Vaginal swab for culture and Metabolic gas signatures detected by Ainos Flora (operated by participant) in people with Vaginal Infection and Vaginitis, run by Taiwan Carbon Nano Technology Corporation at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection, Vaginitis
- What is being tested?
- Vaginal swab for RT-PCR, Vaginal swab for culture and Metabolic gas signatures detected by Ainos Flora (operated by participant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 8 Oct 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
MacKay Memorial Hospital
Taipei, 10449
Dr. Wen-Chu Huang, 886-975835350, wjhuang4438@yahoo.com.tw
Dr. Wen-Chu Huang
- Recruiting
Tri-Service General Hospital
Taipei, 11490
Dr. Fung-Wei Chang, 886-2-87923311 ext. 12304, doc30666@gmail.com
Dr. Fung-Wei Chang
About this study
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.
Read the 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.
- Conditions
- Vaginal Infection, Vaginitis
- Being tested
- Vaginal swab for RT-PCR, Vaginal swab for culture, Metabolic gas signatures detected by Ainos Flora (operated by participant), Metabolic gas signatures detected by Ainos Flora (operated by medical staff)
- Keywords
- E-Nose
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swab for RT-PCRDevice
Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans
Vaginal swab for cultureDevice
Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli
Metabolic gas signatures detected by Ainos Flora (operated by participant)Device
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)Device
The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial infections | Experimental | 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 Receives: 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) |
| Fungal infection : | Experimental | The subject is infected with Candida albicans only. Receives: 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) |
| Mixed infection | Experimental | Bacterial and fungal infections coexist. Receives: 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) |
| No infection | Experimental | Healthy participant Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start8 Oct 2022
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study is a prospective study to evaluate the sensitivity and specificity of the Ainos Flora Female Vaginal Health Tester in identifying vaginal infections. Potential subjects will be patients in the gynecological clinic. The study will evaluate the performance of the Ainos Flora Female Vaginal Health Tester by comparing it to the conventional real-time polymerase chain reaction (RT-PCR) and culture methods for the diagnosis of vaginitis to calculate both sensitivity and specificity.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Carbon Nano Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Responsible party
- Sponsor
- Investigators
- Dr. Fung-Wei Chang, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557318
- Sponsor's protocol ID
- A202203003
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
- ClinicalTrials.gov ID
- NCT05557318
- Acronym / sponsor ID
- A202203003
- Conditions
- Vaginal Infection, Vaginitis
- Keywords
- E-Nose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taiwan Carbon Nano Technology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This clinical study is a prospective study to evaluate the sensitivity and specificity of the Ainos Flora Female Vaginal Health Tester in identifying vaginal infections. Potential subjects will be patients in the gynecological clinic. The study will evaluate the performance of the Ainos Flora Female Vaginal Health Tester by comparing it to the conventional real-time polymerase chain reaction (RT-PCR) and culture methods for the diagnosis of vaginitis to calculate both sensitivity and specificity.
| Arm | Type | Receives |
|---|---|---|
| Bacterial infections | Experimental | 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 at least one of the following pathogens: Bacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhoeae |
| Fungal infection : | Experimental | 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. |
| Mixed infection | Experimental | 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. |
| No infection | Experimental | 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swab for RT-PCRScreening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans | Device | Bacterial infections, Fungal infection :, Mixed infection, No infection |
| Vaginal swab for cultureScreening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli | Device | Bacterial infections, Fungal infection :, Mixed infection, No infection |
| 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 | Bacterial infections, Fungal infection :, Mixed infection, No infection |
| 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. | Device | Bacterial infections, Fungal infection :, Mixed infection, No infection |
Primary outcome
To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.
Time frame: 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
2 secondary outcomes
Assess the change in sensitivity as the number of subjects is changed.
Time frame: Up to 6 months.
Assess the change in specificity as the number of subjects is changed.
Time frame: Up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Fung-Wei Chang principal investigator
Tri-Service General Hospital (TSGH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal swab for RT-PCR, Vaginal swab for culture and Metabolic gas signatures detected by Ainos Flora (operated by participant) in people with Vaginal Infection and Vaginitis, run by Taiwan Carbon Nano Technology Corporation at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Fung-Wei Chang (886-2-87923311 ext. 12304, doc30666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis. (time frame: Up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.