NCT07521735

NEXT GEN - PHILIPS OPTIMUS

SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose 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.

Detailed description

To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.

Conditions

• Pulse Oximetry

Interventions

Type	Name	Description
DEVICE	Philips MR400 Pro MRI Patient Monitor	Philips IntelliVue Patient Monitor X3 Philips Adult SpO2 Sensor (M1191BL) Philips Wireless Patient Module SpO2 (Gen-4) SpO2 Sensor, MRI (Gen-4) Adult SpO2 Glove Adult SpO2 Grips

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-04-03
• Completion: 2026-04-03
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study