A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
NCT03993886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2020-07-17
Summary
Evaluate the performance of the CorBand product when used to monitor patients.
Conditions
- Heart Failure
- Chronic Kidney Diseases
Interventions
- DEVICE
-
CorBand
The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.
- OTHER
-
Activity Monitor
commercially available accelerometer to be worn on wrist
- OTHER
-
Bioimpedance spectrometer
Commercially available bioimpedance monitor.
- OTHER
-
ECG
Commercially available electrocardiogram machine
- OTHER
-
respiratory rate sensor
Commercially available respiratory rate sensor.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
ReThink Medical
lead INDUSTRY
Principal Investigators
-
Jamie Kennedy, MD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-17
- Primary Completion
- 2020-06-30
- Completion
- 2020-07-14
- FDA Device
- Yes
Countries
- United States
Study Locations
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