Actively Recruiting

Age: 18Years - 89Years
All Genders
Healthy Volunteers
ID06402318

A Prospective Observational Validation Study of the A&M Breathalyzer PROTECT Kiosk for COVID-19 Detection in Military Operational Medicine

Led by The Geneva Foundation · Updated on 2025-12-10

100

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

T

The Geneva Foundation

Lead Sponsor

B

Brooke Army Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to optimize and validate innovative passive surveillance systems for detecting COVID-19 and other respiratory diseases in military environments. The study focuses on assessing new diagnostic technologies, specifically the A&M Breathalyzer PROTECT Kiosk, to improve rapid and non-invasive detection of COVID-19 among both symptomatic and asymptomatic individuals. The goal is to enhance military operational readiness by reducing the impact of acute respiratory diseases through better screening methods. The A&M Breathalyzer PROTECT Kiosk, a portable mass spectrometer device, will be tested and modified at Brooke Army Medical Center. It collects breath samples passively without the need for direct breath collection, using sensors analyzed by an integrated AI platform to detect SARS-CoV-2 components. The study includes participants with known positive or negative COVID-19, Flu, or RSV test results obtained within 48 hours of recruitment, comparing breathalyzer results to standard RT-PCR tests. Participants will undergo breath capture sampling and temperature thermal scans, with data collected over a period from at least 48 hours up to 12 months. Researchers will monitor the device’s detection accuracy, sensor performance, and data analyzed by the AI system. The study involves observational monitoring without intervention, aiming to validate the breathalyzer's capability for passive detection in real-world clinical settings to support operational medicine.

CONDITIONS

Brief Title

Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine

Who Can Participate

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Both asymptomatic and symptomatic individuals
  • Undergoing standard COVID-19, Flu, or RSV screening and testing at Brooke Army Medical Center
  • Able to understand and provide consent
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 years
  • Unable to comply with or be assisted in study procedures
  • Unable to provide a temperature thermal scan or perform exhaled breath sampling for about 8 seconds

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Minimum 48 hours up to 12 months

Participants are observed using the A&M Breathalyzer PROTECT Kiosk for passive detection of COVID-19 and other respiratory illnesses.

Multiple visits depending on participant's routine COVID-19, Flu, or RSV testing schedule

Trial Site Locations

Total: 1 location

1

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Actively Recruiting

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Research Team

T

Tony Yuan, PhD

K

Katherine Walker-Rodriguez

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Chemometric analysis of the global pattern of volatile organic compounds in the exhaled breath of patients with COVID-19, post-COVID and healthy subjects. Proof of concept for post-COVID assessment.

Blanca Nohemí Zamora-Mendoza, Lorena Díaz de León-Martínez, Maribel Rodríguez-Aguilar...

https://pubmed.ncbi.nlm.nih.gov/34635222

Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer.

Kelly E van Keulen, Maud E Jansen, Ruud W M Schrauwen...

https://pubmed.ncbi.nlm.nih.gov/31858615