Convenience Sample Data Collection for INVSENSOR00045

NCT04894669 | Terminated Results

• 1 other identifier: CHOC0006
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxygen Saturation

Keywords

Oxygen Saturation; SpO2

Outcome Measures

Primary Outcomes (1)

• Form, Fit and Function of INVSENSOR00045.

  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.

Study Arms (1)

INVSENSOR00045

EXPERIMENTAL

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

Interventions

INVSENSOR00045 DEVICE

Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.

INVSENSOR00045

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Site 2

Orange, California, 92868, United States

Location

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: May 20, 2021
• Study Start: June 11, 2021
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-02

Locations

US (1)