Sinus Balloon Dilation in Pediatric Patients
Status: | Active, not recruiting |
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Conditions: | Sinusitis |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 2 - 21 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | January 2016 |
XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
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.
Allergic to nickel or barium sulfate. Severe asthma. Cystic fibrosis. Immunodeficiency.
Craniofacial abnormalities. Pregnancy (current)
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