Study Stopped
Change in focus by the company.
POMCO2 Clinical Study MicroTrend System pCO2 Sensor
Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedStudy Start
First participant enrolled
November 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedMarch 10, 2023
March 1, 2023
2 months
August 10, 2022
March 8, 2023
Conditions
Keywords
Outcome Measures
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
4-6 hours
Study Arms (1)
MicroTrend System
EXPERIMENTALMicroTrend 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ExoStat Medical, Inc.lead
- Bright Research Partnerscollaborator
Study Sites (1)
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Raul J Gazmuri, MD, PhD
Captain James A. Lovell Federal Health Care Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 12, 2022
Study Start
November 22, 2022
Primary Completion
January 9, 2023
Study Completion
January 9, 2023
Last Updated
March 10, 2023
Record last verified: 2023-03