SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

Spo2 Clinical Trial

Official title:

SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896267
• Other study ID #: BAIL0003
• Status: Completed
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: June 22, 2023

Study information

• Verified date: April 2024
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• 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) to 18 months of age.

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 is not suitable for the investigation at the discretion of the Investigator.

Related Conditions & MeSH terms

• Spo2

Intervention

Device:
• Masimo INVSENSOR00061
Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) in blood .

Locations

Country	Name	City	State
United States	Bailony Pediatrics	National City	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 INVSENSOR00061meets its performance specifications.	Masimo INVSENSOR00061 measurements will be compared to FDA-cleared References	Approximately 15 minutes]