NCT06402318 Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine
| NCT ID | NCT06402318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Geneva Foundation |
| Condition | COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-12-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization. To meet the objective and execute the deliverables for this program of effort, the A\&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings. Goals: 1. Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A\&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.
Eligibility Criteria
Inclusion Criteria: * Asymptomatic and symptomatic individuals 18 years and older * Receiving standard COVID-19, Flu and/or RSV screening and testing at BAMC * Do not have to be diagnosed with SARS-CoV-19 (COVID-19) but only be screened * Ability to understand consent Exclusion Criteria: * Any individual under age of 18 * Anyone unable to comply (or be assisted) with study procedures * Anyone not able to provide temperature thermal scan, and/or perform exhaled breath for approximately 8 seconds
Contact & Investigator
Tony Yuan, PhD
PRINCIPAL INVESTIGATOR
Uniformed Services University of the Health Sciences (USUHS)
Frequently Asked Questions
Who can join the NCT06402318 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06402318 currently recruiting?
Yes, NCT06402318 is actively recruiting participants. Contact the research team at tony.yuan@usuhs.edu for enrollment information.
Where is the NCT06402318 trial being conducted?
This trial is being conducted at Fort Sam Houston, United States.
Who is sponsoring the NCT06402318 clinical trial?
NCT06402318 is sponsored by The Geneva Foundation. The principal investigator is Tony Yuan, PhD at Uniformed Services University of the Health Sciences (USUHS). The trial plans to enroll 100 participants.
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