Monitoring Subjects With Fluid-Management Issues In the Home Environment

Baxter

Status: Completed

Conditions: Hypertension; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02190877

Perm-IRB-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 23 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No 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.

Trial design

23 participants in 1 patient group

Cohort 1: Subjects taking diuretic medication

Description:

All subjects will be in the same group, Cohort 1