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NCT05926648 Clinical Trial

Form, Fit, and Function of INVSENSOR00061

Healthy Clinical Trial

Official title:
Form, Fit, and Function of INVSENSOR00061

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05926648
Other study ID # CIP-1077
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2023
Est. completion date March 28, 2024

Study information
Verified date May 2024
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date March 28, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 37 Weeks to 18 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• INVSENSOR00061
Noninvasive pulse oximetry, pulse rate, and temperature device

Locations
Country Name City State
United States Masimo Corporation Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary SpO2 (Oxygen saturation in blood) Data Collection in Pediatric Patients using INVSENSOR00061 meets its performance specifications. Masimo INVSENSOR00061 measurements will be compared to FDA-cleared References 2 hours to 48 hours
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