Surgical Reduction of the Inferior Turbinates for Nasal Obstruction - Full Text View

Sponsor:	ArthroCare Corporation
Information provided by (Responsible Party):	ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00737906

Purpose

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	Intervention	Phase
Chronic Rhinitis Inflammation of the Nasal Mucosa Inflammation of Nasal Tissue	Procedure: Surgical turbinate reduction procedure	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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

Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment. [ Time Frame: Through 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I Surgical turbinate reduction procedure	Procedure: Surgical turbinate reduction procedure Surgical turbinate reduction using the COBLATION device

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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is >=6 and <=17 years old.
Patient has had symptoms of nasal obstruction for >=6 months.
Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
Patient (or guardian) must sign IRB approved informed consent form.

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737906

Locations

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

Investigators

Principal Investigator:

Anthony M Magit, MD

Children's Associated Medical Group, San Diego, CA

More Information

Publications:

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. Review.

Chang CW, Ries WR. Surgical treatment of the inferior turbinate: new techniques. Curr Opin Otolaryngol Head Neck Surg. 2004 Feb;12(1):53-7. Review.

Responsible Party:	ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00737906 History of Changes
Other Study ID Numbers:	E-505DHH
Study First Received:	August 18, 2008
Last Updated:	October 10, 2011
Health Authority:	United States: Institutional Review Board

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
Coblation
Arthrocare

ENT
Failed Medical Management for Chronic Sinusitis
Turbinate
Inferior Turbinate Hypertrophy
Bilateral Inferior Turbinate Hypertrophy
Turbinate Hypertrophy
Inferior Turbinate
Bilateral Inferior Turbinate

Additional relevant MeSH terms:

Rhinitis
Inflammation
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Otorhinolaryngologic Diseases
Pathologic Processes
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders

ClinicalTrials.gov processed this record on February 09, 2012