Trials / Completed
CompletedNCT03396835
Desaturation Validation of INVSENSOR00009
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.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 arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00009 | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2018-01-16
- Completion
- 2018-01-16
- First posted
- 2018-01-11
- Last updated
- 2019-08-28
- Results posted
- 2019-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03396835. Inclusion in this directory is not an endorsement.