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NCT05264116 · ClinicalTrials.gov registry record · NA
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions
A NA study, sponsored by Stryker Sustainability Solutions.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT05264116: Completed NA study, sponsored by Stryker Sustainability Solutions.
NCT05264116 is a NA study that has completed, run by Stryker Sustainability Solutions. 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
NCT05264116, a NA study, has completed, sponsored by Stryker Sustainability Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.
Primary Outcome
Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation
Interventions
- DEVICE STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2022-02-03 |
| Phase | NA |
What the finished NCT05264116 record still lists
NCT05264116 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 STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS is the first listed.
NCT05264116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05264116 about?
NCT05264116 is a clinical study titled "SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions". The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentatio...
What is the current status of trial NCT05264116?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2022-02-02. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT05264116?
The interventions under investigation include: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS (DEVICE).
Who is sponsoring clinical trial NCT05264116?
This trial is sponsored by Stryker Sustainability Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05264116'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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