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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 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03570255
The ClinicalTrials.gov registry entry for NCT03570255 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masimo Corporation, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RD SET Neo SpO2 is the first listed.
NCT03570255 reports 0 study locations.
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.
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