Trial Outcomes & Findings for Convenience Sample Data Collection for INVSENSOR00045 (NCT NCT04894669)
NCT ID: NCT04894669
Last Updated: 2025-04-10
Results Overview
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
TERMINATED
7 participants
Up to 8 hours per subject.
2025-04-10
Participant Flow
Participant milestones
| Measure |
INVSENSOR00045
All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.
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|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Convenience Sample Data Collection for INVSENSOR00045
Baseline characteristics by cohort
| Measure |
INVSENSOR00045
n=7 Participants
All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Non-Hispanic, Latino or Spanish Origin
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2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino, or Spanish Origin
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 hours per subject.Population: Data was obtained from all participants and there were no signal quality issues. The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the root mean square error (RMS) could not be computed.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
Outcome measures
| Measure |
INVSENSOR00045
n=7 Participants
All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation.
|
|---|---|
|
Form, Fit and Function of INVSENSOR00045.
|
0 number of issues with form/fit &function
|
Adverse Events
INVSENSOR00045
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place