Status:
TERMINATED
Surgical Reduction of the Inferior Turbinates for Nasal Obstruction
Lead Sponsor:
ArthroCare Corporation
Conditions:
Chronic Rhinitis
Inflammation of the Nasal Mucosa
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.
Detailed Description
Chronic rhinitis, or inflammation of the nasal mucosa, is one of the most common causes of nasal obstruction in the pediatric population. Chronic rhinitis may result in mucous gland hypertrophy, engor...
Eligibility Criteria
Inclusion
- Patient is \>=6 and \<=17 years old.
- Patient has had symptoms of nasal obstruction for \>=6 months.
- Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
- Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
- Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
- Patient (or guardian) must sign IRB approved informed consent form.
Exclusion
- Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
- Septal deviation
- Concha bullosa
- Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)
- Nasal polyps
- Nasal valve collapse.
- Patient has been diagnosed with obstructive sleep apnea not originating from the turbinates.
- Patient has active or chronic upper airway infection that may contribute to nasal obstruction (not including chronic rhinosinusitis).
- 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).
- Patient has systemic disease affecting the nasal passage(e.g. Wegener's granulomatosis).
- Patient is receiving or has received immunotherapy (any type) within 12 months of enrollment.
- Patient has a nasal septal perforation.
- Patient has had any previous turbinate surgery.
- Patient has had any previous nasal surgery.
- Patient has had any sinus surgery within 6 months of enrollment.
- Patient has had an adenoidectomy within 3 months of enrollment.
- Patient is pregnant or potentially pregnant.
- Patient or caregiver is incapable of understanding or responding to the study questionnaires.
- Patient is participating in another clinical study during the 12 month enrollment period.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00737906
Start Date
October 1 2007
End Date
October 1 2012
Last Update
August 26 2015
Active Locations (5)
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1
Children's Hospital of San Diego
San Diego, California, United States, 92123
2
The Children's Hospital
Aurora, Colorado, United States, 80045
3
Center for Pediatric ENT
Boynton Beach, Florida, United States, 33437
4
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207