Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00037 (NCT NCT04002973)
NCT ID: NCT04002973
Last Updated: 2020-10-20
Results Overview
This study will evaluate the trending accuracy of the INVSENSOR00037 relative to the reference value obtained from the comparative FDA-cleared device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1-5 hours
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
INVSENSOR00037
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.
INVSENSOR00037: Noninvasive regional oximeter.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Desaturation Validation of INVSENSOR00037
Baseline characteristics by cohort
| Measure |
INVSENSOR00037
n=11 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.
INVSENSOR00037: Noninvasive regional oximeter.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-5 hoursThis study will evaluate the trending accuracy of the INVSENSOR00037 relative to the reference value obtained from the comparative FDA-cleared device.
Outcome measures
| Measure |
INVSENSOR00037
n=11 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.
INVSENSOR00037: Noninvasive regional oximeter.
|
|---|---|
|
Trending Accuracy of the INVSENSOR00037
|
1.8 percentage of regional oxygen saturation
|
Adverse Events
INVSENSOR00037
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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