Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

NCT04380389 | Completed Results FDA Device

• 1 other identifier: pulse ox
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oximetry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

profound hypoxia

OTHER

Diagnostic Test: hypoxia

Interventions

hypoxia DIAGNOSTIC_TEST

Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.

profound hypoxia

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is male or female, aged ≥18 and \<50.
• The subject is in good general health with no evidence of any medical problems.
• The subject has both wrist circumferences between 14 and 22cm.
• The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if:

• The subject is obese (BMI\>30).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• The subject has piercings that may cause air leaks during the test
• The subject has any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.

Sponsors & Collaborators

• Withings: lead

Study Sites (1)

Hypoxia Lab, UCSF

San Francisco, California, 94133, United States

Location

Related Publications (1)

• 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.

  PMID: 33857011 DERIVED

Related Links

• Pulse Oximeters - Premarket Notification Submissions \[510(k)s\] Guidance for Industry and Food and Drug Administration Staff, March 4, 2013
• ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Results Point of Contact

• Title: Withings Clinical Team
• Organization: Withings

clinical-trials@withings.com

+ 33(0) 1 41 46 04 60

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: March 11, 2020
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)