NCT06211530

Wireless Disposable SpO2 Sensor Hypoxia Testing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.

Detailed description

The primary objective of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data (simulating blood sample Spo2) on adult human subjects. Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive laboratory testing on healthy adult volunteers) The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.

Conditions

• SpO2
• Peripheral Oxygen Saturation Measurement

Interventions

Type	Name	Description
DEVICE	SpO2 Sensor Testing	Participants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Timeline

• Start date: 2024-01-30
• Primary completion: 2024-02-08
• Completion: 2024-02-08
• First posted: 2024-01-18
• Last updated: 2025-04-30
• Results posted: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study