Status:
COMPLETED
Sinus Balloon Dilation in Pediatric Patients
Lead Sponsor:
Entellus Medical, Inc.
Conditions:
Sinusitis
Eligibility:
All Genders
2-21 years
Phase:
NA
Brief Summary
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
Eligibility Criteria
Inclusion
- Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.
Exclusion
- History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02278484
Start Date
September 1 2014
End Date
January 1 2016
Last Update
April 11 2017
Active Locations (4)
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1
North Valley ENT
Phoenix, Arizona, United States, 85032
2
Willamette ENT and Facial Plastic Surgery
Salem, Oregon, United States, 97302
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Alamo ENT and Associates
San Antonio, Texas, United States, 78258