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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Subjects taking diuretic medication | All subjects will be in the same group, Cohort 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use | 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 | Each subject will be measured once per weekday over a 6 week period |
| Measure | Description | Time Frame |
|---|---|---|
| SKin irritation and reproducibility | 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 | Each subject will be measured once per weekday over a 6 week period |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or more diuretic medication(s) prescribed by a physician
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Banet, PhD | Baxter Healthcare Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Meadows | Riverside | California | 92505 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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