Sinus Balloon Dilation in Pediatric Patients



Status:Active, not recruiting
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:2 - 21
Updated:4/21/2016
Start Date:September 2014
End Date:January 2016

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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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