N/A
Completed N=50
Sinus Balloon Dilation in Pediatric Patients
Source: ClinicalTrials.gov NCT02278484 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Technical Success: Sinuses Successfully Treated With Balloon Dilation — 157 sinus dilation attempts
Summary
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success: Sinuses Successfully Treated With Balloon Dilation |
157 | — |
| PRIMARY Complications |
— | — |
| SECONDARY Change in Quality of Life From Baseline Through Completion |
-2.9 | <0.0001 sig |
| SECONDARY Number of Subjects Who Undergo a Revision or Additional Surgery During the Study |
— | — |
Eligibility Criteria
Inclusion Criteria
Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.
Exclusion Criteria
History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
Data sourced from ClinicalTrials.gov (NCT02278484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.