N/A
Completed N=64
SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
Spo2
Source: ClinicalTrials.gov NCT05896267 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: SpO2 Accuracy of INVSENSOR00061 — 0.87 percent of oxygen saturated hemoglobin
Summary
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SpO2 Accuracy of INVSENSOR00061 |
0.87 | — |
| PRIMARY Pulse Rate Accuracy of INVSENSOR00061 |
4.45 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05896267). 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. Informational only — not medical advice.