Form, Fit, and Function of INVSENSOR00061

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.

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Key information

Conditions

Healthy

Age range

0 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

INVSENSOR00061

Device

Noninvasive pulse oximetry and pulse rate device

Primary outcomes

INVSENSOR00061 SpO2 Accuracy

Time frame: 2 hours

The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref_i) in accordance with ISO-80601-2-61.

Arms= √(∑(i=1 to n) ((SpO2_i-SpO2ref_i )^2 ))/n

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 3, 2023
Registry last updated: Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed