Monitoring Subjects With Fluid-Management Issues In the Home Environment

N/ACompletedNCT02190877

Baxter Healthcare Corporation23 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure Hypertension

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Riverside Meadows

Riverside, California, United States

Outcomes

Primary Outcomes

Ease of Use

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

Time frame: Each subject will be measured once per weekday over a 6 week period

Secondary Outcomes

SKin irritation and reproducibility

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

Time frame: Each subject will be measured once per weekday over a 6 week period

Data from ClinicalTrials.gov

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