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JessieHug Feasibility and Usability Assessment
Sponsor: Weill Medical College of Cornell University
Summary
The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data. The main questions it aims to answer are: * Is the device easily usable for parents of newborns and infants? * Is the device tolerable when worn by infants and are there any safety concerns? * Is the device able to collect clinically accurate physiologic data compared to a FDA-cleared reference device? Participants will: * Place the JessieHug device on their infant two times a week and complete surveys to assess usability, tolerability and safety. * Have one session where the JessieHug device will be worn at the same time as reference device to determine accuracy.
Key Details
Gender
All
Age Range
0 Months - 4 Months
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-04-10
Completion Date
2026-07-01
Last Updated
2025-05-23
Healthy Volunteers
Yes
Conditions
Interventions
JessieHug
Assessment of JessieHug device when placed on infants.
Locations (1)
NewYork Presbyterian - Weill Cornell Medical Center
New York, New York, United States