- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00737906
Surgical Reduction of the Inferior Turbinates for Nasal Obstruction
Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92123
- Children's Hospital of San Diego
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Colorado
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Aurora, Colorado, United States, 80045
- The Children's Hospital
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Florida
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Boynton Beach, Florida, United States, 33437
- Center for Pediatric ENT
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Kentucky
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Louisville, Kentucky, United States, 40207
- Advanced ENT & Allergy
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Ohio
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Columbus, Ohio, United States, 43205
- Pediatric Otolaryngology Nationwide Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Septal deviation
- Concha bullosa
- Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)
- Nasal polyps
- 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.
Study Plan
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
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Surgical turbinate reduction using the COBLATION device
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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
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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
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Through 12 months
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony M Magit, MD, Children's Associated Medical Group, San Diego, CA
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- 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
Other Study ID Numbers
- E-505DHH
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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