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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02190877

Enrollment

Registered

2014-07-15

Start date

2014-04-30

Completion date

2014-05-31

Last updated

2014-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Hypertension

Keywords

Heart Failure, Impedance, Fluids

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results