NCT07215429

SpO2 Validation Study-Philips Optimus

SpO2 Validation Study - Philips Optimus

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Validation study to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry

Detailed description

The intent of this clinical study is to validate the SpO2 accuracy performance of the Sponsor's 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 Sponsor's pulse oximeter with consideration to anticipated updates to ISO 80601-2-61:2025(E)

Conditions

• Pulse Oximetry, Oxygen Measurements, SpO2

Interventions

Type	Name	Description
DEVICE	No intervention	No intervention

Timeline

• Start date: 2025-09-09
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2025-10-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study