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NCT03831282 · ClinicalTrials.gov registry record · NA
Feasibility and Performance Evaluation of INVSENSOR00024
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03831282: Completed NA study, sponsored by Masimo Corporation.
NCT03831282 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03831282, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
Primary Outcome
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences
Interventions
- DEVICE RD SET Neo SpO2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2019-05-28 |
| Phase | NA |
What the finished NCT03831282 record still lists
NCT03831282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which RD SET Neo SpO2 is the first listed.
NCT03831282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03831282 about?
NCT03831282 is a clinical study titled "Feasibility and Performance Evaluation of INVSENSOR00024". This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
What is the current status of trial NCT03831282?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-02-08. Estimated completion is 2019-05-28.
What interventions are being tested in trial NCT03831282?
The interventions under investigation include: RD SET Neo SpO2 (DEVICE).
Who is sponsoring clinical trial NCT03831282?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03831282's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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