Last reviewed · How we verify
NCT06833294
GentleFit Non-Invasive Ventilation (NIV) Interface Trial
trial testing GentleFit Mask, GentleFit Prong, Standard of Care Interface in Device Ineffective in 4 participants. Terminated before completion.
20 January 2026
Quick facts
| Lead sponsor | Children's Hospital of Philadelphia |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 4 |
| Start date | 24 October 2025 |
| Primary completion | 20 January 2026 |
| Estimated completion | 20 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GentleFit Mask, GentleFit Prong, Standard of Care Interface
Conditions studied
- Device Ineffective — all drugs for Device Ineffective →
- Device Induced Injury — all drugs for Device Induced Injury →
Sponsor
Children's Hospital of Philadelphia
Who can join
Adults 38 Weeks to 3, any sex, with Device Ineffective or Device Induced Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06833294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06833294 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06833294.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing