HypoperfusionNCT05499624
POMCO2 Clinical Study MicroTrend System pCO2 Sensor
A study testing MicroTrend System in people with Hypoperfusion, run by ExoStat Medical, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hypoperfusion
- What is being tested?
- MicroTrend System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
About this study
Official title: Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
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.
- Conditions
- Hypoperfusion
- Being tested
- MicroTrend System
- Keywords
- Oral mucosal carbon dioxide pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroTrend SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MicroTrend System | Experimental | 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. Receives: Device: MicroTrend System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start22 Nov 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Why it stopped: Change in focus by the company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoperfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- ExoStat Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Raul J Gazmuri, MD, PhD, Principal investigator, Captain James A. Lovell Federal Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499624
- Sponsor's protocol ID
- EXO-CL-5000
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
- ClinicalTrials.gov ID
- NCT05499624
- Acronym / sponsor ID
- EXO-CL-5000
- Conditions
- Hypoperfusion
- Keywords
- Oral mucosal carbon dioxide pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in focus by the company.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ExoStat Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MicroTrend System | Experimental | Device: MicroTrend SystemMicroTrend 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroTrend SystemThe 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. | Device | MicroTrend System |
Primary outcome
Correlation between POMCO2
Time frame: 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
Results and safety
The study was stopped early (reason given: Change in focus by the company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul J Gazmuri, MD, PhD principal investigator
Captain James A. Lovell Federal Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroTrend System in people with Hypoperfusion, run by ExoStat Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in focus by the company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between POMCO2 (time frame: 4-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.