Monitoring Subjects With Fluid-Management Issues In the Home Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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

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Heart Failure Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1: Subjects taking diuretic medication

All subjects will be in the same group, Cohort 1

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No