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Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737906
Recruitment Status : Terminated
First Posted : August 20, 2008
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
ArthroCare Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Rhinitis Inflammation of the Nasal Mucosa Inflammation of Nasal Tissue Procedure: Surgical turbinate reduction procedure Phase 4

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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
Study Start Date : October 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: I
Surgical turbinate reduction procedure
Procedure: Surgical turbinate reduction procedure
Surgical turbinate reduction using the COBLATION device

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment. [ Time Frame: Through 12 months ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737906

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United States, California
Children's Hospital of San Diego
San Diego, California, United States, 92123
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Florida
Center for Pediatric ENT
Boynton Beach, Florida, United States, 33437
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, Ohio
Pediatric Otolaryngology Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
ArthroCare Corporation
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Principal Investigator: Anthony M Magit, MD Children's Associated Medical Group, San Diego, CA
Additional Information:
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Responsible Party: ArthroCare Corporation Identifier: NCT00737906    
Other Study ID Numbers: E-505DHH
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by ArthroCare Corporation:
Chronic rhinitis
Nasal Obstruction
Nasal Obstruction Symptoms
Failed Medical Management for Nasal Obstruction
Inflammation of the nasal mucosa
Pediatric Turbinate reduction
Failed Medical Management for Chronic Sinusitis
Inferior Turbinate Hypertrophy
Bilateral Inferior Turbinate Hypertrophy
Turbinate Hypertrophy
Inferior Turbinate
Bilateral Inferior Turbinate
Additional relevant MeSH terms:
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Nasal Obstruction
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders