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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: Completed NA study, sponsored by Masimo Corporation.
NCT05674136 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SpO2 accuracy was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n
Interventions
- DEVICE INVSENSOR00061
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2022-12-07 |
| Phase | NA |
What the finished NCT05674136 record still lists
NCT05674136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00061 is the first listed.
NCT05674136 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05674136's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 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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