Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

This is an interventional treatment trial for Chronic Rhinitis focused on measuring Chronic rhinitis, Nasal Obstruction, Nasal Obstruction Symptoms, Failed Medical Management for Nasal Obstruction, Inflammation of the nasal mucosa, Pediatric Turbinate reduction, Coblation, Arthrocare, ENT, Failed Medical Management for Chronic Sinusitis, Turbinate, Inferior Turbinate Hypertrophy, Bilateral Inferior Turbinate Hypertrophy, Turbinate Hypertrophy, Inferior Turbinate, Bilateral Inferior Turbinate Read More

Inclusion Criteria:

1. Patient is >=6 and <=17 years old.
2. Patient has had symptoms of nasal obstruction for >=6 months.
3. Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
4. Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
5. Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
6. Patient (or guardian) must sign IRB approved informed consent form.

Exclusion Criteria:

1. Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:

   1. Septal deviation
   2. Concha bullosa
   3. Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)
   4. Nasal polyps
   5. Nasal valve collapse.
2. Patient has been diagnosed with obstructive sleep apnea not originating from the turbinates.
3. Patient has active or chronic upper airway infection that may contribute to nasal obstruction (not including chronic rhinosinusitis).
4. Patient has active coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery).
5. Patient has systemic disease affecting the nasal passage(e.g. Wegener's granulomatosis).
6. Patient is receiving or has received immunotherapy (any type) within 12 months of enrollment.
7. Patient has a nasal septal perforation.
8. Patient has had any previous turbinate surgery.
9. Patient has had any previous nasal surgery.
10. Patient has had any sinus surgery within 6 months of enrollment.
11. Patient has had an adenoidectomy within 3 months of enrollment.
12. Patient is pregnant or potentially pregnant.
13. Patient or caregiver is incapable of understanding or responding to the study questionnaires.
14. Patient is participating in another clinical study during the 12 month enrollment period.