POMCO2 Clinical Study MicroTrend System pCO2 Sensor

Sponsor

ExoStat Medical, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05499624

Collaborator

Bright Research Partners (Industry)

Enrollment

Location

Arm

Anticipated Duration (Days)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoperfusion	Device: MicroTrend System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Correlation between POMCO2 [4-6 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct
Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Captain James A. Lovell Federal Health Care Center	North Chicago	Illinois	United States	60064

Sponsors and Collaborators

ExoStat Medical, Inc.
Bright Research Partners

Investigators

Principal Investigator: Raul J Gazmuri, MD, PhD, Captain James A. Lovell Federal Health Care Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ExoStat Medical, Inc.

ClinicalTrials.gov Identifier:

NCT05499624

Other Study ID Numbers:

EXO-CL-5000

First Posted:

Aug 12, 2022

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by ExoStat Medical, Inc.

Oral mucosal carbon dioxide pressure

Study Results

No Results Posted as of Aug 12, 2022