A Prospective, Non-interventional, Observational Clinical Validation Study to Analytically Validate the A&M Breathalyzer PROTECT Kiosk Breath Capture System.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: t
View:

• Asymptomatic and symptomatic individuals 18 years and older

• Receiving standard COVID-19 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

Locations
United States
Texas
Brooke Army Medical Center
RECRUITING
Fort Sam Houston
Contact Information
Primary
Tony Yuan, PhD
tony.yuan@usuhs.edu
214-292-0508
Backup
Katherine Walker-Rodriguez
katherine.c.walker-rodriguez.ctr@health.mil
2103783057
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 100
Treatments
COVID-19 positive patients
Participants screened with known COVID-19 positive results obtained within 48 hours of recruitment.
COVID-19 negative patients
Participants screened with known COVID-19 negative results obtained within 48 hours of recruitment.
Sponsors
Collaborators: Brooke Army Medical Center, Level 42 AI, Inc., Uniformed Services University of the Health Sciences
Leads: The Geneva Foundation

This content was sourced from clinicaltrials.gov