Convenience Sample Data Collection for INVSENSOR00045

April 8, 2025 updated by: Masimo Corporation
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Less than or equal to 1 month of age
  • Gestational age greater than 23 weeks
  • Weight less than or equal to 5 kg
  • Subjects with standard of care arterial blood sampling line already in place

Exclusion Criteria:

  • 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
  • Subjects with axillary arterial lines
  • Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INVSENSOR00045
All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
Device: INVSENSOR00045
Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Form, Fit and Function of INVSENSOR00045.
Time Frame: Up to 8 hours per subject.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
Up to 8 hours per subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

May 21, 2023

Study Completion (Actual)

May 21, 2023

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHOC0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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