Status:
TERMINATED
Convenience Sample Data Collection for INVSENSOR00045
Lead Sponsor:
Masimo Corporation
Conditions:
Oxygen Saturation
Eligibility:
All Genders
Up to 1 years
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04894669
Start Date
June 11 2021
End Date
May 21 2023
Last Update
April 10 2025
Active Locations (1)
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1
Site 2
Orange, California, United States, 92868