Trials / Completed
CompletedNCT03570255
Feasibility and Performance Evaluation for INVSENSOR00024
Feasibility and Performance Evaluation of INVSENSOR00024
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Accepted
Summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RD SET Neo SpO2 | All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. |
Timeline
- Start date
- 2018-06-25
- Primary completion
- 2019-11-08
- Completion
- 2019-11-08
- First posted
- 2018-06-26
- Last updated
- 2020-02-20
- Results posted
- 2020-02-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03570255. Inclusion in this directory is not an endorsement.