Status:
COMPLETED
Monitoring Subjects With Fluid-Management Issues In the Home Environment
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Heart Failure
Hypertension
Eligibility:
All Genders
21-90 years
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 d...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02190877
Start Date
April 1 2014
End Date
May 1 2014
Last Update
July 23 2014
Active Locations (1)
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1
Riverside Meadows
Riverside, California, United States, 92505