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

NCT05557318 | Recruiting

• 1 other identifier: A202203003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaginal Infection; Vaginitis

Keywords

E-Nose

Outcome Measures

Primary Outcomes (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.

  * 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 Outcomes (2)

• Assess the change in sensitivity as the number of subjects is changed.

  Up to 6 months.

• Assess the change in specificity as the number of subjects is changed.

  Up to 6 months.

Study Arms (4)

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

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.

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.

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

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)

Interventions

Vaginal swab for RT-PCR DEVICE

Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans

Bacterial infections; Fungal infection :; Mixed infection; No infection

Vaginal swab for culture DEVICE

Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli

Bacterial infections; Fungal infection :; Mixed infection; No infection

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.

Bacterial infections; Fungal infection :; Mixed infection; No infection

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.

Bacterial infections; Fungal infection :; Mixed infection; No infection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

MacKay Memorial Hospital

Taipei, 10449, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Vaginitis

Interventions

Reverse Transcriptase Polymerase Chain Reaction; Culture Techniques

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; In Vitro Techniques

Study Officials

• Dr. Fung-Wei Chang

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Fung-Wei Chang

CONTACT

886-2-87923311; doc30666@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: October 8, 2022
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)