Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

August 25, 2015 updated by: ArthroCare Corporation

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • Children's Hospital of San Diego
    • Colorado
      • Aurora, Colorado, United States, 80045
        • The Children's Hospital
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Center for Pediatric ENT
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT & Allergy
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Pediatric Otolaryngology Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Surgical turbinate reduction procedure
Surgical turbinate reduction using the COBLATION device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 weeks, 6 months, 12 months
6 weeks, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.
Time Frame: Through 12 months
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
6 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony M Magit, MD, Children's Associated Medical Group, San Diego, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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