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RECRUITING
NCT06466148
NA

JessieHug Feasibility and Usability Assessment

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

DEVICE

JessieHug

Assessment of JessieHug device when placed on infants.

Locations (1)

NewYork Presbyterian - Weill Cornell Medical Center

New York, New York, United States