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NCT06402318 · ClinicalTrials.gov registry record

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

A clinical trial of COVID-19 and COVID-19 Respiratory Infection, sponsored by The Geneva Foundation.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT06402318 is a study of COVID-19 and COVID-19 Respiratory Infection that is actively recruiting participants, run by The Geneva Foundation. The registered enrollment target is 100 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06402318, a study of COVID-19 and COVID-19 Respiratory Infection, is actively recruiting participants, sponsored by The Geneva Foundation.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DEVICE A&M Breathalyzer PROTECT Kiosk

Study Locations (1)

Texas

  • Brooke Army Medical Center - Fort Sam Houston

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-12-27
Est. Completion 2026-03-30

Sponsor

The Geneva Foundation

11 total trials

What the Registry Record Tells You About NCT06402318

The ClinicalTrials.gov registry entry for NCT06402318 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is The Geneva Foundation, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which A&M Breathalyzer PROTECT Kiosk is the first listed.

NCT06402318 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT06402318 about?

NCT06402318 is a clinical study titled "Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine". 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 delive...

What is the current status of trial NCT06402318?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2023-12-27. Estimated completion is 2026-03-30.

What conditions does trial NCT06402318 study?

This clinical trial studies the following conditions: COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia, COVID-19 Acute Respiratory Distress Syndrome, SARS-CoV-2 Virus.

What interventions are being tested in trial NCT06402318?

The interventions under investigation include: A&M Breathalyzer PROTECT Kiosk (DEVICE).

Who is sponsoring clinical trial NCT06402318?

This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06402318 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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