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Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| profound hypoxia | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypoxia | Diagnostic Test | Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RMSE Compared to CO-oximetry | 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypoxia Lab, UCSF | San Francisco | California | 94133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33857011 | Derived | Kirszenblat R, Edouard P. Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study. J Med Internet Res. 2021 Apr 26;23(4):e27503. doi: 10.2196/27503. |
| Label | URL |
|---|---|
| Pulse Oximeters - Premarket Notification Submissions \[510(k)s\] Guidance for Industry and Food and Drug Administration Staff, March 4, 2013 | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Continuous value of the age of the subjects in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RMSE Compared to CO-oximetry | 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. | Posted | Number | RMSE (%) | No | 1 hour | samples | samples |
|
|
On the day of the visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Withings Clinical Team | Withings | + 33(0) 1 41 46 04 60 | clinical-trials@withings.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2020 | Feb 27, 2026 | Prot_SAP_000.pdf |
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| ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | View source |
| Mean |
| Standard Deviation |
| year |
|
| Sex: Female, Male | Sex of the participant | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Skin tone | Skin tone of the subjects | Count of Participants | Participants |
|
| BMI (kg/m²) | Body mass index of the subject | Mean | Standard Deviation | kg.m-² |
|
| Height | Continuous height of the subjects | Mean | Standard Deviation | cm |
|
| Weight | Continuous weight of the subjects | Mean | Standard Deviation | kg |
|
| Participants |
|
| samples |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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.