SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
1 other identifier
interventional
64
1 country
1
Brief Summary
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2023
CompletedFirst Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2023
CompletedResults Posted
Study results publicly available
March 12, 2025
CompletedNovember 12, 2025
October 1, 2025
1 month
May 31, 2023
April 8, 2024
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
SpO2 Accuracy of INVSENSOR00061
SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Approximately 15 minutes
Pulse Rate Accuracy of INVSENSOR00061
Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.
Approximately 15 minutes
Study Arms (1)
Masimo INVSENSOR00061
EXPERIMENTALExperimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.
Interventions
Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )
Eligibility Criteria
You may qualify if:
- Subject is a full-term newborn (37 weeks) to 18 months of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bailony Pediatrics
National City, California, 91950, United States
Results Point of Contact
- Title
- Chelsea Frank
- Organization
- Masimo Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 9, 2023
Study Start
May 15, 2023
Primary Completion
June 22, 2023
Study Completion
June 22, 2023
Last Updated
November 12, 2025
Results First Posted
March 12, 2025
Record last verified: 2025-10