Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia

Part of paid clinical trials in San Francisco, California.

Sponsor
Movano Health
Study ID
NCT06459206
Status
Recruiting
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Conditions

  • Hypoxia

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Pulse oximeter — DEVICE
    Devices (4) were placed on the finger base and the fingertip of two right or left fingers and placed in motion for the duration of the study. Devices (3) were placed on the contralateral side and maintained motionless for the duration of the of study. Blood samples were taken at each stable level of oxygenation.

Study Details

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Key Dates

Start date
Jun 11, 2024
Status verified
Jun 2024
Primary completion
Jun 13, 2024
Completion
Jun 13, 2024

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: Healthy Adult Volunteers
    Minimum of ten (10) subjects meeting the eligibility criteria.

Primary Outcome Measure

Test devices oxygen saturation accuracy [ Time Frame: 2 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hypoxia Research LaboratorySan FranciscoCalifornia94133
Philip Bickler, MD

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Hypoxia Research Laboratory· San Francisco, CA

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