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A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.
The study has the following objectives: Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device
Age
21 - 90 years
Sex
ALL
Healthy Volunteers
No
Riverside Meadows
Riverside, California, United States
Start Date
April 1, 2014
Primary Completion Date
May 1, 2014
Completion Date
May 1, 2014
Last Updated
July 23, 2014
23
ACTUAL participants
Lead Sponsor
Baxter Healthcare Corporation
NCT02417740
NCT07191730
Data Source & Attribution
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