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

NCT05557318 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

    collaborator INDUSTRY

  • Taiwan Carbon Nano Technology Corporation

    lead INDUSTRY

Principal Investigators

  • Dr. Fung-Wei Chang · Tri-Service General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-08
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557318 on ClinicalTrials.gov