Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425172
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-30
Brief Title:
Monitoring System for Cranial Orthoses
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Monitoring System for Cranial Remolding Orthoses
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study which investigates the wear time and fit of a cranial remolding orthosis a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow
Detailed Description:
This is a study which investigates the wear time and fit of a cranial remolding orthosis a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow Although cranial remolding treatment has been used successfully for over 20 years there is no clinical standard for objective monitoring of the fit and wear time
In total participation will consist of 7 visits over 11 weeks 1 measurements and clinical evaluation approximately 60 minutes 2 fitting of standard helmet and pre-fitting andor fitting of the research helmet approximately 60 minutes 3 fitting of research helmet if not done at Visit 2 and in-office testing approximately 2 hours 456 follow up visits for research helmet approximately 30-60 minutes each and 7 final follow up visit and in-office testing for the research helmet approximately 2 hours
During the 8-9 weeks of wearing the research helmet the child is expected to wear the it 23 hours per day after a break-in schedule and caregivers will keep a log of helmet wear time and any side effects such as skin irritations if they occur The child will be seen clinically every 2 weeks or more often if caregivers request additional checkups
At the end of the trial participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet
In total participation will consist of 7 visits over 11 weeks 1 measurements and clinical evaluation approximately 60 minutes 2 fitting of standard helmet and pre-fitting andor fitting of the research helmet approximately 60 minutes 3 fitting of research helmet if not done at Visit 2 and in-office testing approximately 2 hours 456 follow up visits for research helmet approximately 30-60 minutes each and 7 final follow up visit and in-office testing for the research helmet approximately 2 hours
During the 8-9 weeks of wearing the research helmet the child is expected to wear the it 23 hours per day after a break-in schedule and caregivers will keep a log of helmet wear time and any side effects such as skin irritations if they occur The child will be seen clinically every 2 weeks or more often if caregivers request additional checkups
At the end of the trial participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None