N/A
N=20
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02265783 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed — 98.7 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nellcor USB Pulse Oximeter Monitor Interface Cable (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed |
98.7 | — |
Summary
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 18 or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Exclusion Criteria
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Data sourced from ClinicalTrials.gov (NCT02265783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.