Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466148
Status:
SUSPENDED
Last Update Posted:
2024-06-20
First Post:
2024-06-12
Brief Title:
JessieHug Feasibility and Usability Assessment
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
JessieHug Feasibility and Usability Assessment
Status:
SUSPENDED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Creating clearer charging instructions and distributing surge protectors
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study evaluates the usability tolerability and clinical accuracy of the JessieHug device a wearable medical device for newborns and infants that continuously collects physiological data Three cohorts of infants will be enrolled newborn 2-month and 4-month groups with each cohort undergoing data collection over a total of eight 8 weeks The JessieHug device will be assessed for usability and tolerability through parental surveys while the baby wears the device in home and hospital settings Clinical accuracy of the device will be evaluated through comparison to an FDA cleared reference device in a single outpatient clinic-based data collection event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None