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NCT03570255 · ClinicalTrials.gov registry record · NA
Feasibility and Performance Evaluation for INVSENSOR00024
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03570255: Completed NA study, sponsored by Masimo Corporation.
NCT03570255 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03570255, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
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 | 28 participants |
| Start Date | 2018-06-25 |
| Est. Completion | 2019-11-08 |
| Phase | NA |
What the finished NCT03570255 record still lists
NCT03570255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which RD SET Neo SpO2 is the first listed.
NCT03570255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03570255 about?
NCT03570255 is a clinical study titled "Feasibility and Performance Evaluation for INVSENSOR00024". This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of...
What is the current status of trial NCT03570255?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2018-06-25. Estimated completion is 2019-11-08.
What interventions are being tested in trial NCT03570255?
The interventions under investigation include: RD SET Neo SpO2 (DEVICE).
Who is sponsoring clinical trial NCT03570255?
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 NCT03570255's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 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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