Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
Primary Purpose
Vaginal Infection, Vaginitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginal Infection focused on measuring E-Nose
Eligibility Criteria
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.
Sites / Locations
- MacKay Memorial Hospital
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Bacterial infections
Fungal infection :
Mixed infection
No infection
Arm Description
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
The subject is infected with Candida albicans only.
Bacterial and fungal infections coexist.
Healthy participant
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05557318
First Posted
September 21, 2022
Last Updated
September 26, 2022
Sponsor
Taiwan Carbon Nano Technology Corporation
Collaborators
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05557318
Brief Title
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
Official Title
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Carbon Nano Technology Corporation
Collaborators
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
4. Oversight
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
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infection, Vaginitis
Keywords
E-Nose
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bacterial infections
Arm Type
Experimental
Arm Description
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
Arm Title
Fungal infection :
Arm Type
Experimental
Arm Description
The subject is infected with Candida albicans only.
Arm Title
Mixed infection
Arm Type
Experimental
Arm Description
Bacterial and fungal infections coexist.
Arm Title
No infection
Arm Type
Experimental
Arm Description
Healthy participant
Intervention Type
Device
Intervention Name(s)
Vaginal swab for RT-PCR
Intervention Description
Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans
Intervention Type
Device
Intervention Name(s)
Vaginal swab for culture
Intervention Description
Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli
Intervention Type
Device
Intervention Name(s)
Metabolic gas signatures detected by Ainos Flora (operated by participant)
Intervention Description
The participant operates the Ainos Flora to collect signatures of metabolic gases in the vagina by herself.
Intervention Type
Device
Intervention Name(s)
Metabolic gas signatures detected by Ainos Flora (operated by medical staff)
Intervention Description
The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.
Primary Outcome Measure Information:
Title
To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.
Description
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.
Secondary Outcome Measure Information:
Title
Assess the change in sensitivity as the number of subjects is changed.
Description
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.
Title
Assess the change in specificity as the number of subjects is changed.
Description
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Fung-Wei Chang
Phone
886-2-87923311
Ext
12304
Email
doc30666@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Fung-Wei Chang
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacKay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Wen-Chu Huang
Phone
886-975835350
Email
wjhuang4438@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Dr. Wen-Chu Huang
First Name & Middle Initial & Last Name & Degree
Dr. Chia-Sui Weng
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Fung-Wei Chang
Phone
886-2-87923311
Ext
12304
Email
doc30666@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Fung-Wei Chang
First Name & Middle Initial & Last Name & Degree
Dr. Chi-Kang Lin
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
We'll reach out to this number within 24 hrs