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Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
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.
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Pediatric Otolaryngology Nationwide Children's Hospital
Columbus, Ohio, United States
Start Date
October 1, 2007
Primary Completion Date
October 1, 2012
Completion Date
October 1, 2012
Last Updated
August 26, 2015
30
ACTUAL participants
Surgical turbinate reduction procedure
PROCEDURE
Lead Sponsor
ArthroCare Corporation
NCT05324397
NCT04769596
Data Source & Attribution
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