Form, Fit, and Function of INVSENSOR00061

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: INVSENSOR00061

• Registration Number: NCT05926648
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-07-03
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subjects	INVSENSOR00061	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVENSOR00061

Primary Outcome Measures

Name	Time	Method
INVSENSOR00061 SpO2 Accuracy	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

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States