NCT07527000

SpO2 Validation Study - All.Health Algo Oximeter Software

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: All Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The purpose of this clinical study is to validate the SpO2 accuracy performance of the all.health SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the all.health pulse oximeter. 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. An investigational device will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Additional devices may be placed on the biceps, forehead, or on the back of the wrist with the arterial catheter (secured with Tegaderm instead of wrist strap). The site(s) where sensors are placed will be measured. Simultaneous data collection will be set up for the device under test and control oximeter.

Conditions

• Device Performance
• Healthy Adult Volunteers

Interventions

Type	Name	Description
DEVICE	No intervention (observational study)	No intervention

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-05-04
• Completion: 2027-05-04
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study