Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 1:10 PM
Study NCT ID:
NCT06833294
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GentleFit Non-Invasive Ventilation (NIV) Interface Trial
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2025-11
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:
The primary objective is to compare pressure achieved by GentleFit Non-Invasive Ventilation (NIV) nasal mask and nasal prong to standard of care interface. Secondary objectives include to monitor skin integrity, clinical parameters, and adverse events. Additionally, to evaluate clinician opinion of ease of application and overall fit of GentleFit NIV interfaces and headgear.
Detailed Description:
Current NIV interfaces commercially available do not address all size and anatomical gaps present in the pediatric population. To overcome this challenge, nasal mask and nasal prong prototype interfaces have been designed to fill some of the current size gap. These interfaces, known as GentleFit NIV, need to be trialed to ensure appropriateness of design and patient tolerance for 4-8 hour application intervals, as is standard of practice for current devices on the market.
Study Oversight
Has Oversight DMC:
False
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?: