Form, Fit, and Function of INVSENSOR00061

Completed · Not applicable

Conditions studied: Healthy

In brief

The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.

Key facts

Study ID

NCT05926648

Run by

Masimo Corporation

People needed

53

Starts

2023-05-12

Expected to finish

2024-03-28

Last updated by the study team

2024-09-25

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is a full-term newborn (37 weeks) - up to 18 months of age.
• The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.

You may not qualify if…

• Subject has underdeveloped skin.
• Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
• Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
• Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Where it is running

• Masimo Corporation — Irvine, California, United States

Full record on ClinicalTrials.gov

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