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.
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, engorgement of the vascular system and deposition of collagen in the nasal mucosa. These changes occur most prominently in the inferior turbinate, causing enlargement and nasal obstruction. In children, inferior turbinate hypertrophy is associated with a greater degree of nasal obstruction relative to adults because of their small nasal anatomy. Cases that do not respond to conservative treatments may be considered for one of many surgical procedures, including turbinate excision, submucosal resection, submucosal cautery, laser treatment, cryosurgery, powered microdebridement, or radiofrequency-based ablation. Clinical studies have shown that bipolar radiofrequency-based plasma (Coblation®) devices are capable of creating focal submucosal lesions with minimal or no damage to structures adjacent to the treated area. At present, however, this technique has not been formally evaluated in children. This study will investigate whether surgical turbinate reduction performed using a Coblation device is associated with reduced nasal obstruction symptoms that has failed to improve with other treatment methodologies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Surgical turbinate reduction using the COBLATION device
Children's Hospital of San Diego
San Diego, California, United States
The Children's Hospital
Aurora, Colorado, United States
Center for Pediatric ENT
Boynton Beach, Florida, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.
Time frame: 6 weeks, 6 months, 12 months
Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.
Time frame: Through 12 months
To assess durability of treatment using: a. Self-reported obstructive symptoms measures b. Physical examination measures, d. Blinded evaluation of anterior rhinoscopy images
Time frame: 6 weeks, 6 months, 12 months
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Pediatric Otolaryngology Nationwide Children's Hospital
Columbus, Ohio, United States