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POMCO2 Clinical Study MicroTrend System pCO2 Sensor

NCT05499624 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-03-10

No results posted yet for this 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.

Conditions

  • Hypoperfusion

Interventions

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.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • ExoStat Medical, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2023-01-09
Completion
2023-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499624 on ClinicalTrials.gov