NCT02190877

Monitoring Subjects With Fluid-Management Issues In the Home Environment

A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Heart Failure
• Hypertension

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-07-15
• Last updated: 2014-07-23

Locations

1 site across 1 country: United States