N/A
N=53
Form, Fit, and Function of INVSENSOR00061
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05926648 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: INVSENSOR00061 SpO2 Accuracy — 1.02 % of SpO2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INVSENSOR00061 (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY INVSENSOR00061 SpO2 Accuracy |
1.02 | — |
Summary
The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.
Eligibility Criteria
Inclusion Criteria
- Subject is a full-term newborn (37 weeks) - up to 18 months of age.
- The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.
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 has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Data sourced from ClinicalTrials.gov (NCT05926648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.