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Clinical Trial Summary

A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.


Clinical Trial Description

The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01899911
Study type Interventional
Source LifeWatch Services, Inc.
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date March 2013

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