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NCT04017611 · ClinicalTrials.gov registry record · NA
Desaturation Validation of INVSENSOR00038
A NA study of Healthy, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04017611: Completed NA study of Healthy, sponsored by Masimo Corporation.
NCT04017611 is a NA study of Healthy that has completed, run by Masimo Corporation. The registered enrollment target is 13 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04017611, a NA study of Healthy, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-cleared sensor placed on the somatic site on the contralateral side. Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
Primary Outcome
This study will evaluate the trending accuracy of the INVSENSOR00038 relative to the reference value obtained from the comparative FDA-cleared device.
Conditions Studied
Interventions
- DEVICE INVSENSOR00038
Study Locations (1)
California
- Masimo Corporation - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2019-07-19 |
| Phase | NA |
What the finished NCT04017611 record still lists
NCT04017611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which INVSENSOR00038 is the first listed.
NCT04017611 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04017611 about?
NCT04017611 is a clinical study titled "Desaturation Validation of INVSENSOR00038". This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the refere...
What is the current status of trial NCT04017611?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2019-07-08. Estimated completion is 2019-07-19.
What conditions does trial NCT04017611 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04017611?
The interventions under investigation include: INVSENSOR00038 (DEVICE).
Who is sponsoring clinical trial NCT04017611?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04017611 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04017611's enrollment target sits among peer trials
13 986th of 1090 higher than 96 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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