A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases; Heart Failure
• Interventions: Device: CorBand; Other: ECG; Other: Activity Monitor; Other: respiratory rate sensor; Other: Bioimpedance spectrometer

• Registration Number: NCT03993886
• Lead Sponsor: ReThink Medical

Brief Summary

Evaluate the performance of the CorBand product when used to monitor patients.

Detailed Description

The goal of the study is to demonstrate the validity and reliability of the CorBand across a suite of six clinical measures by comparing the measurements to similar outputs of FDA cleared devices:

* CorBand heart rate and heart rate variability will be compared to an electrocardiogram.

* CorBand bioimpedance will be compared to recorded extracted fluid and a bioimpedance measurement device.

* CorBand respiration rate will be compared to an respiratory rate sensor.

* CorBand skin temperature will be compared to a skin temperature monitoring device.

* CorBand activity will be compared to an activity monitor.

* CorBand outputs will be compared to the outputs of the CardioMEMS system.

Device safety, comfort, and ease-of-use will also be evaluated as part of this study. Adverse events and serious adverse events will be documented throughout the study duration.

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Primary Completion: 2020-06-30
• Status Verified: 2020-07
• Study Completion: 2020-07-14
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	respiratory rate sensor	Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management.
Arm 3	CorBand	Adult (≥ 18 years of age) patients (i) implanted with the CardioMEMS HF device and (ii) diagnosed with heart failure and/or undergoing cardiac management.
Arm 4	CorBand	Adult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management.
Arm 1	ECG	Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management.
Arm 2	CorBand	Adult (≥ 18 years of age) patients undergoing chronic hemodialysis.
Arm 2	Bioimpedance spectrometer	Adult (≥ 18 years of age) patients undergoing chronic hemodialysis.
Arm 1	CorBand	Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management.
Arm 2	Activity Monitor	Adult (≥ 18 years of age) patients undergoing chronic hemodialysis.

Primary Outcome Measures

Name	Time	Method
Study Endpoint: Skin Temperature	Through study completion, an average of 1 week	To evaluate the accuracy of the skin temperature data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Activity	Through study completion, an average of 1 week	To evaluate the accuracy of the activity (steps/movement) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Heart Rate	Through study completion, an average of 1 week	To evaluate the accuracy of the heart rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Respiration Rate	Through study completion, an average of 1 week	To evaluate the accuracy of the respiration rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Heart Rate Variability	Through study completion, an average of 1 week	To evaluate the accuracy of the heart rate variability data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Bioimpedance (Extracellular fluid differences)	Through study completion, an average of 1 week	To evaluate the accuracy of the bioimpedance (extracellular fluid differences) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Satellite Healthcare; 🇺🇸 San Jose, California, United States