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SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

NCT06149416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-06

Study results available
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Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.

Conditions

Interventions

DEVICE

Experimental Masimo RD SET SpO2 Adhesive Sensors

Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)

Sponsors & Collaborators

  • Stryker Sustainability Solutions

    lead INDUSTRY

Principal Investigators

  • Philip Bickler, MD, PhD · UCSF Hypoxia Research Laboratory

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-27
Primary Completion
2023-05-28
Completion
2023-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149416 on ClinicalTrials.gov