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TerminatedNCT05499624Updated Mar 10, 2023

POMCO2 Clinical Study MicroTrend System pCO2 Sensor

An interventional study of MicroTrend System in Hypoperfusion, sponsored by ExoStat Medical, Inc.. Terminated at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by ExoStat Medical, Inc. · Not applicable, Interventional, and Basic science

Why this study was terminated
Change in focus by the company.

From the registry’s dates

  • Primary completion was Jan 2023, 3 years 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

The objective of this non-significant risk (NSR) study is to evaluate the safety and efficacy of the MicroTrend System by correlating POMCO2 data with relevant clinical metrics including arterial pressure and heart rate.

Read the detailed description

This is a prospective, single-center, non-randomized, non-significant risk (NSR) study evaluating the safety and efficacy of the MicroTrend System, which is indicated for monitoring oral mucosal carbon dioxide pressure (POMCO2) in hospital patients.

02

Conditions studied

  • Hypoperfusion

Keywords

  • Oral mucosal carbon dioxide pressure
03

In context

Lead sponsor

This is the only study on the registry with ExoStat Medical, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Hospitalized adult (age 22 years and older) in the critical care unit
  2. Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable)
  3. Willing and physically able to comply with the study protocol and procedures

Exclusion criteria

Exclusion Criteria:

  1. Evidence of intra- or peri-oral, buccal, or gingival disease or trauma to the face or mouth that may interfere with MicroTrend System that is deemed clinically significant by the investigator
  2. Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct
  3. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    MicroTrend System

    MicroTrend System is placed onto the subject's cheek and the subject will actively participate in the study for up to 6 hours, with up to 4 hours of sensor monitoring.

    Device: MicroTrend System

Interventions

  • DeviceMicroTrend System

    The hands-free device measures oral mucosal carbon dioxide pressure (POMCO2) and functions outside of the body and does not require a surgical procedure or any significant deviation from standard practice to operate.

06

What researchers measure

Primary outcomes

  1. Correlation between POMCO2

    Assessed by the MicroTrend System and the relevant clinical metrics of mean arterial pressure and heart rate. Statistically significant correlations (defined as p \< 0.05) will be deemed success for this purpose, with adjustment for multiplicity by the Hochberg-Holm method

    Time frame: 4-6 hours

07

Study locations

1 site
  • Captain James A. Lovell Federal Health Care Center
    North Chicago, Illinois 60064, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05499624
Lead sponsor
ExoStat Medical, Inc.
Collaborators
Bright Research Partners
Responsible party
Sponsor
First posted
Aug 12, 2022
Start date
Nov 22, 2022
Primary completion
Jan 9, 2023
Completion
Jan 9, 2023
Last update
Mar 10, 2023

Study contacts

Raul J Gazmuri, MD, PhD
principal investigator · Captain James A. Lovell Federal Health Care Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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