Monitoring Subjects With Fluid-Management Issues In the Home Environment

Completed

• Conditions: Hypertension; Heart Failure

• Registration Number: NCT02190877
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
• Subject will have a current prescription for a diuretic medication.
• Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
• Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria

• Subject is participating in another clinical study that may affect the results of either study.
• Subject is unable or not willing to wear electrode patches as required.
• Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
• Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
• Subject is considered by the PI to be medically unsuitable for study participation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ease of Use	Each subject will be measured once per weekday over a 6 week period	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

Secondary Outcome Measures

Name	Time	Method
SKin irritation and reproducibility	Each subject will be measured once per weekday over a 6 week period	Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device

Trial Locations

Locations (1)

Riverside Meadows; 🇺🇸 Riverside, California, United States