Stopped: The clinical study was terminated ahead of schedule due to the availability of next-generation devices.
United States24 participantsStarted 2025-09-09
Plain-language summary
Validation study to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
Participants accepted in this study must meet all the following criteria:
* Participant must have the ability to understand and provide written informed consent.
* Participant is an adult between 18-50 years of age.
* Participant must be willing and able to comply with study procedures and duration.
* Participant is a non-smoker or who has not smoked within 2 days prior to the study.
EXCLUSION CRITERIA
* Participant is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
* Females who are pregnant
* Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
* Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
* Participants with known respiratory conditions such as: (self-reported)
* uncontrolled / severe asthma,
* flu,
* pneumonia / bronchitis,
* shortnes…
What they're measuring
1
SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring