Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia

NCT06459206 | Recruiting FDA Device

• 1 other identifier: MOVA06
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Test devices oxygen saturation accuracy

  Root Mean Squared Error (RMSE) between test devices in motion and motionless saturation of peripheral oxygen and arterial oxygen saturation.

  2 days

Study Arms (1)

Healthy Adult Volunteers

Minimum of ten (10) subjects meeting the eligibility criteria.

Device: Pulse oximeter

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.

Healthy Adult Volunteers

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.

You may qualify if:

• 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.

You may not qualify if:

• Subject is obese with a body mass index (BMI) over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease.
• Subject has asthma, sleep apnea, or uses continuous positive airway pressure breathing support 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.

Sponsors & Collaborators

• Movano Health: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Hypoxia Research Laboratory

San Francisco, California, 94133, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Bickler, MD, PhD

  University of California at San Francisco (UCSF)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Tompkins

CONTACT

+1 (408) 981-488; ktompkins@movano.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: June 11, 2024
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)