NCT05557318

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taiwan Carbon Nano Technology Corporation · Industry
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Infection
• Vaginitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-08
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2022-09-28
• Last updated: 2024-04-10

Locations

2 sites across 1 country: Taiwan