A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Ease of Use
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- SKin irritation and reproducibility(Each subject will be measured once per weekday over a 6 week period)