Viewing Study NCT03207802


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Study NCT ID: NCT03207802
Status: COMPLETED
Last Update Posted: 2019-09-10
First Post: 2017-06-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Remotely Monitoring Patients With Chronic Conditions in Their Home
Sponsor: Baxter Healthcare Corporation
Organization:

Study Overview

Official Title: Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion
Status: COMPLETED
Status Verified Date: 2018-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: