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Completed

NCT Number: NCT02190877

Monitoring Subjects With Fluid-Management Issues In the Home Environment

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riverside Meadows

Riverside, California, 92505, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Ease of Use

    Time frame: 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 outcomes

  1. SKin irritation and reproducibility

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2014
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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