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GentleFit Non-Invasive Ventilation (NIV) Interface Trial

NCT06833294 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Device Ineffective
  • Device Induced Injury

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Natalie Napolitano, PhD · Children's Hospital of Philadelphia

Eligibility

Min Age
38 Weeks
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2026-01-20
Completion
2026-01-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833294 on ClinicalTrials.gov