Trials / Terminated
TerminatedNCT06833294
GentleFit Non-Invasive Ventilation (NIV) Interface Trial
Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 38 Weeks – 3 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GentleFit Mask, GentleFit Prong, Standard of Care Interface | The subject will be randomized to sequence of interfaces. The subject will wear each of three NIV interfaces for 8 cumulative hours, for a total of 24 hours. Pressure achieved using each GentleFit interface will be compared to pressure achieved by standard of care interface. In the event either the GentleFit nasal mask or nasal prong does not appropriately fit the subject, a standard of care interface will be substituted. |
Timeline
- Start date
- 2025-10-24
- Primary completion
- 2026-01-20
- Completion
- 2026-01-20
- First posted
- 2025-02-18
- Last updated
- 2026-02-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06833294. Inclusion in this directory is not an endorsement.