Feasibility and Performance Evaluation for INVSENSOR00024

Completed · Not applicable

Conditions studied: Evaluation of SpO2 Performance

In brief

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Key facts

Study ID

NCT03570255

Run by

Masimo Corporation

People needed

28

Starts

2018-06-25

Expected to finish

2019-11-08

Last updated by the study team

2020-02-20

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Less than or equal to 1 month of age
• Weight <3kg
• Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

You may not qualify if…

• Subjects with underdeveloped skin
• Subjects with abnormalities at the planned application sites that would interfere with system measurements
• Subjects with known allergic reactions to foam/rubber products and adhesive tape
• Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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