JessieHug Feasibility and Usability Assessment

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: t
View:

• Healthy neonates and infants, with cohorts defined by the following age ranges:

‣ newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days),

⁃ 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days),

• Born after 37 0/7 weeks of pregnancy

• Parent or legal guardian at time of discharge is able to understand and provide consent for participation

• Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study

• Parent or legal guardian is fluent in English

• Parent or legal guardian has access to the internet

Locations
United States
New York
NewYork Presbyterian - Weill Cornell Medical Center
RECRUITING
New York
Contact Information
Primary
James M Kim, MD
jmk9018@med.cornell.edu
978-886-2791
Backup
Martha Liu, MS
mal4038@med.cornell.edu
+1 646-962-4668
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 50
Treatments
Experimental: Newborn Cohort
The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.
Experimental: 2 month Cohort
The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.
Experimental: 4 month Cohort
The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.
Related Therapeutic Areas
Sponsors
Collaborators: Empatica, Inc.
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov