Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Surgical turbinate reduction procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical turbinate reduction procedure | Procedure | Surgical turbinate reduction using the COBLATION device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony M Magit, MD | Children's Associated Medical Group, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of San Diego | San Diego | California | 92123 | United States | ||
| The Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11190749 | Background | Hol MK, Huizing EH. Treatment of inferior turbinate pathology: a review and critical evaluation of the different techniques. Rhinology. 2000 Dec;38(4):157-66. | |
| 14712123 | Background | Chang CW, Ries WR. Surgical treatment of the inferior turbinate: new techniques. Curr Opin Otolaryngol Head Neck Surg. 2004 Feb;12(1):53-7. doi: 10.1097/00020840-200402000-00015. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 weeks, 6 months, 12 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Center for Pediatric ENT | Boynton Beach | Florida | 33437 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | United States |
| Pediatric Otolaryngology Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |