Trials / Terminated
TerminatedNCT05499624
POMCO2 Clinical Study MicroTrend System pCO2 Sensor
Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- ExoStat Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-11-22
- Primary completion
- 2023-01-09
- Completion
- 2023-01-09
- First posted
- 2022-08-12
- Last updated
- 2023-03-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05499624. Inclusion in this directory is not an endorsement.