SpO2 Validation Study - All.Health Algo Oximeter Software

Part of paid clinical trials in Louisville, Colorado.

Sponsor
All Health, Inc.
Study ID
NCT07527000
Status
Completed

Conditions

  • Device Performance
  • Healthy Adult Volunteers

Eligibility Criteria

Sex
ALL
Age
22 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • No intervention (observational study) — DEVICE
    No intervention

Study Details

The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. all.health is dedicated to developing and applying innovative electronic medical solutions that improve patient care with the Algo Oximeter Software, to be used in applications for monitoring oxygen saturation.

Key Dates

Start date
Apr 27, 2026
Status verified
May 2026
Primary completion
May 7, 2026
Completion
May 7, 2026

Study Design

Enrollment
25 participants (actual)

Arms

  • Arm: all.health wristband
    The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The all.health wristband will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Simultaneous data collection will be set up for the device under test and control oximeter.

Primary Outcome Measure

SP02 accuracy [ Time Frame: April 2026-May 2026 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Element Materials TechnologyLouisvilleColorado80027-

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