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NCT05765396 · ClinicalTrials.gov registry record
SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
A clinical trial of COVID-19 and Influenza, sponsored by The Geneva Foundation.
- Active
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT05765396 is a study of COVID-19 and Influenza that is active but no longer recruiting, run by The Geneva Foundation. The registered enrollment target is 300 participants, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05765396, a study of COVID-19 and Influenza, is active but no longer recruiting, sponsored by The Geneva Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19, Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19, Flu, and/or RSV. The hypotheses are: (H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their usability between the devices. (H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic Respiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those not infected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR and molecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their captured traces in the early identification of disease/illness analyzed by the devices built in algorithms. (H3) In the mid to long-term, this approach will also be explored as a diagnostic system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments. Participants will: * Be consented; * Be screened for COVID-19, Flu, and/or RSV symptoms according to BAMC's current screening procedures; * Have st
Conditions Studied
Interventions
- DEVICE imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope
Study Locations (1)
Texas
- Brooke Army Medical Center - Fort Sam Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2026-03-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05765396
The ClinicalTrials.gov registry entry for NCT05765396 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The listed sponsor is The Geneva Foundation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope is the first listed.
NCT05765396 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05765396 about?
NCT05765396 is a clinical study titled "SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies". The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19, Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19, Flu, and/or RSV screening an...
What is the current status of trial NCT05765396?
This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2023-05-15. Estimated completion is 2026-03-30.
What conditions does trial NCT05765396 study?
This clinical trial studies the following conditions: COVID-19, Influenza, Corona Virus Infection, RSV Infection, COVID-19 Respiratory Infection.
What interventions are being tested in trial NCT05765396?
The interventions under investigation include: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope (DEVICE).
Who is sponsoring clinical trial NCT05765396?
This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05765396 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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Related
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