Sinus Balloon Dilation in Pediatric Patients
This trial is active, not recruiting.
|Treatment||xpress device and pathassist confirmation tools|
|Sponsor||Entellus Medical, Inc.|
|Start date||September 2014|
|End date||September 2015|
|Trial size||50 participants|
|Trial identifier||NCT02278484, 2827-001|
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of subjects who successfully undergo sinus balloon dilation procedure
time frame: Index procedure
Number of subjects who experience complications
time frame: Index procedure through 3 month follow up
Male or female participants from 2 years up to 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)
|Official title||XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study|
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