Clinical trial NCT05557318: 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
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Infection
Vaginitis
Keywords: E-Nose
Lead sponsor: Taiwan Carbon Nano Technology Corporation
Sponsor class: INDUSTRY
Collaborators: name: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
First posted: 2022-09-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.
timeFrame: Up to 6 months.
Secondary outcomes:
measure: Assess the change in sensitivity as the number of subjects is changed.
timeFrame: Up to 6 months.
measure: Assess the change in specificity as the number of subjects is changed.
timeFrame: Up to 6 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Dr. Fung-Wei Chang
role: PRINCIPAL_INVESTIGATOR
References: