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NCT05674136 · ClinicalTrials.gov registry record · NA
Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT05674136 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 62 participants.
The verdict
NCT05674136, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 80601-2-61 standard which is also adopted and referenced by the FDA.
Interventions
- DEVICE INVSENSOR00061
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2022-12-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674136
The ClinicalTrials.gov registry entry for NCT05674136 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 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 INVSENSOR00061 is the first listed.
NCT05674136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05674136 about?
NCT05674136 is a clinical study titled "Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo". This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 8060...
What is the current status of trial NCT05674136?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2022-11-18. Estimated completion is 2022-12-07.
What interventions are being tested in trial NCT05674136?
The interventions under investigation include: INVSENSOR00061 (DEVICE).
Who is sponsoring clinical trial NCT05674136?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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