Trials / Completed
CompletedNCT07221526
SPO2 VALIDATION STUDY - PHILIPS FAST 2025
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 86 (actual)
- Sponsor
- Philips Clinical & Medical Affairs Global · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
Detailed description
The primary objective of this clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NO INTERVENTION | NO INTERVENTION |
Timeline
- Start date
- 2025-10-28
- Primary completion
- 2026-02-05
- Completion
- 2026-02-05
- First posted
- 2025-10-28
- Last updated
- 2026-04-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07221526. Inclusion in this directory is not an endorsement.