Status:
COMPLETED
BodyGuardian Respiration and Activity Validation Testing
Lead Sponsor:
Preventice
Collaborating Sponsors:
Mayo Clinic
Conditions:
Healthy
Eligibility:
All Genders
18-80 years
Brief Summary
This project will compare BodyGuardian (BG) device measurements of breathing and activity levels to the gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and ga...
Detailed Description
BodyGuardian remote monitoring system is an FDA 510 cleared device used to perform remote monitoring of cardiac patients. BodyGuardian (BG) is a novel remote care platform. It incorporates an adhesive...
Eligibility Criteria
Inclusion
- Healthy Volunteers between the ages of 18-80
- Heart Failure Patients/ Volunteers between the ages of 18-80
Exclusion
- Healthy - Non Ambulatory. With Pacemaker. Not able to sign consent.
- Hospitalized in last 6 months for fractures, myocardial infarcts, cancer related surgery, chemo therapy. Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy
- Heart Failure - Non Ambulatory. With Pacemaker. Not able to sign consent.
- Hospitalized in last 6 months for fractures, cancer related surgery, chemo therapy.
- Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02255526
Start Date
September 1 2014
End Date
July 1 2016
Last Update
April 11 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905