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

• Sponsor: Taiwan Carbon Nano Technology Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05557318
• Collaborator: Ainos, Inc. (f/k/a Amarillo Biosciences Inc. (Industry)
• Enrollment: 120
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 4
• Patients Per Site: 60
• Patients Per Site Per Month: 14.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Infection; Vaginitis	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)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Diagnostic
• Official Title: Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis. [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

Secondary Outcome Measures

1. Assess the change in sensitivity as the number of subjects is changed. [Up to 6 months.]

   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.

2. Assess the change in specificity as the number of subjects is changed. [Up to 6 months.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MacKay Memorial Hospital	Taipei		Taiwan	10449
2	Tri-Service General Hospital	Taipei		Taiwan	11490

Sponsors and Collaborators

• Taiwan Carbon Nano Technology Corporation
• Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Investigators

• Principal Investigator: Dr. Fung-Wei Chang, Tri-Service General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taiwan Carbon Nano Technology Corporation
• ClinicalTrials.gov Identifier: NCT05557318
• Other Study ID Numbers: A202203003
• First Posted: Sep 28, 2022
• Last Update Posted: Sep 28, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Taiwan Carbon Nano Technology Corporation: E-Nose
• Additional relevant MeSH terms: Vaginitis; Vaginal Discharge

Study Results

No Results Posted as of Sep 28, 2022