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Clinical Trials/NCT03207802
NCT03207802CompletedNot Applicable

Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion

Baxter Healthcare Corporation1 site in 1 country36 target enrollmentStarted: June 21, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Data correlation

Study Overview

Brief Summary

Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.

Detailed Description

Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
22 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic Disease including CHF
  • Currently receiving home health care
  • Recent discharge for a CHF event

Exclusion Criteria

  • Skin reaction to electrodes
  • Inability to take measurements due to low BMI

Outcomes

Primary Outcomes

Data correlation

Time Frame: 2-6 months

Correlation between data collection and potential heart failure event

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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