Trial Outcomes & Findings for Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia (NCT NCT04380389)
NCT ID: NCT04380389
Last Updated: 2026-05-04
Results Overview
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
COMPLETED
NA
14 participants
1 hour
2026-05-04
Participant Flow
First enrolment: 2020/03/11 Last subject completed: 2020/03/12 The study included eligible volunteers at UCSF. The investigators selected subjects, balanced in terms of gender, age, and skin pigmentation. Participation to the study was offered to the subjects until the target headcounts was reached.
Participant milestones
| Measure |
Left vs Right Hand
Each subject wore two subject devices, one on each wrist. The device on the left wrist was next to the catheter.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Left vs Right Hand
n=14 Participants
Each subject wore two subject devices, one on each wrist. The device on the left wrist was next to the catheter.
|
|---|---|
|
Age, Continuous
|
27.1 year
STANDARD_DEVIATION 3.9 • n=14 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
|
Skin tone
Fair skin tone
|
4 Participants
n=14 Participants
|
|
Skin tone
Medium skin tone
|
7 Participants
n=14 Participants
|
|
Skin tone
Dark skin tone
|
3 Participants
n=14 Participants
|
|
BMI (kg/m²)
|
23.4 kg.m-²
STANDARD_DEVIATION 2.1 • n=14 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION 9.8 • n=14 Participants
|
|
Weight
|
66.6 kg
STANDARD_DEVIATION 8.6 • n=14 Participants
|
PRIMARY outcome
Timeframe: 1 hourRoot Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
Outcome measures
| Measure |
Left Bias
n=244 samples
The device is placed on the left wrist
|
Right Bias
n=275 samples
The device is placed on the right wrist
|
|---|---|---|
|
RMSE Compared to CO-oximetry
|
2.97 RMSE (%)
|
3.00 RMSE (%)
|
Adverse Events
Left vs Right Hand
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 WITHINGS will obtain the exclusive profit and ownership of all results and data derived from the Services, whatever their nature, as well as all related intellectual property rights. WITHINGS will therefore be entitled to freely dispose of them in particular in the context of his scientific, industrial and commercial activities.
- Publication restrictions are in place
Restriction type: OTHER