Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

Chronic Rhinitis Clinical Trial

Official title:

Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737906
• Other study ID #: E-505DHH
• Status: Terminated
• Phase: Phase 4
• First received: August 18, 2008
• Last updated: August 25, 2015
• Start date: October 2007
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• Source: ArthroCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinitis
• Inflammation
• Inflammation of Nasal Tissue
• Inflammation of the Nasal Mucosa
• Nasal Obstruction

Intervention

Procedure:
• Surgical turbinate reduction procedure
Surgical turbinate reduction using the COBLATION device

Locations

Country	Name	City	State
United States	The Children's Hospital	Aurora	Colorado
United States	Center for Pediatric ENT	Boynton Beach	Florida
United States	Pediatric Otolaryngology Nationwide Children's Hospital	Columbus	Ohio
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Children's Hospital of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ArthroCare Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.		Through 12 months	Yes
Secondary	To assess durability of treatment using: a. Self-reported obstructive symptoms measures b. Physical examination measures, d. Blinded evaluation of anterior rhinoscopy images		6 weeks, 6 months, 12 months	No