Detecting vaginal infections using a specialized device

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

This study is testing a new device that uses special technology to see if it can accurately detect vaginal infections in women.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 20 Years to 50 Years
• Sex: Female
• Sponsor: Taiwan Carbon Nano Technology Corporation (industry)
• Locations: 2 sites (Taipei and 1 other locations)
• Trial ID: NCT05557318 on ClinicalTrials.gov

What this trial studies

This clinical study aims to train an algorithm and evaluate the performance of the Ainos Flora Women's Vaginal Health Tester, which utilizes electronic nose technology to identify vaginal infections. The device analyzes metabolized gases produced by vaginal bacteria through a Micro-Electro-Mechanical Systems (MEMS) gas sensor array and an Artificial Neural Network algorithm. The study focuses on assessing the sensitivity and specificity of the device, which will inform the feasibility and sample size for future pivotal clinical trials.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20 to 50 who have had sexual experience and can provide informed consent.

Not a fit: Patients who are menstruating, have recently performed vaginal washing, or have been treated for vaginal infections within the past week may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive and accurate method for diagnosing vaginal infections.

How similar studies have performed: While the use of electronic nose technology in medical diagnostics is emerging, this specific application for vaginal infections is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Taipei and 1 other locations

• MacKay Memorial Hospital — Taipei, Taiwan (RECRUITING)
• Tri-Service General Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Dr. Fung-Wei Chang — Tri-Service General Hospital
• Study coordinator: Dr. Fung-Wei Chang

Conditions: Vaginal Infection, Vaginitis, E-Nose