Status:
COMPLETED
Accuracy of Evie Ring Pulse Oximeter in Profound Hypoxia
Lead Sponsor:
Movano Health
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Hypoxia
Eligibility:
All Genders
18-49 years
Brief Summary
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per ISO 80601-2-61:2019. Four devices were placed on each subject with two on each index finger at the ...
Detailed Description
The study is an open enrollment, single-center, single blinded design using the investigational ring compared to arterial blood gas measurements (SaO2) and to two commercially available hospital grade...
Eligibility Criteria
Inclusion
- Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures.
- Subject is willing to have their skin color assessed.
Exclusion
- Subject is obese with a BMI over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease.
- Subject has asthma, sleep apnea, or uses a CPAP. Subject has diabetes. Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
- Subject has any other serious system illness. Subject is a current smoker. Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
- Subject has a history of fainting or vasovagal response. Subject has a sensitivity to local anesthesia. Subject has Raynaud's disease. Subject has unacceptable collateral circulation based on an exam by the investigator.
- Subject is pregnant, lactating, or trying to get pregnant. Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
- Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.
Key Trial Info
Start Date :
January 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06101654
Start Date
January 9 2024
End Date
January 10 2024
Last Update
March 13 2024
Active Locations (1)
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1
Hypoxia Research Laboratory
San Francisco, California, United States, 94133