Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

NCT00737906 | Terminated Phase 4

• 1 other identifier: E-505DHH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Rhinitis; Inflammation of the Nasal Mucosa; Inflammation of Nasal Tissue

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

Outcome Measures

Primary Outcomes (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.

  6 weeks, 6 months, 12 months

Secondary Outcomes (2)

• Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.

  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

  6 weeks, 6 months, 12 months

Study Arms (1)

I

EXPERIMENTAL

Surgical turbinate reduction procedure

Procedure: Surgical turbinate reduction procedure

Interventions

Surgical turbinate reduction procedure PROCEDURE

Surgical turbinate reduction using the COBLATION device

I

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ArthroCare Corporation: lead

Study Sites (5)

Children's Hospital of San Diego

San Diego, California, 92123, United States

Location

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Center for Pediatric ENT

Boynton Beach, Florida, 33437, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Pediatric Otolaryngology Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 11190749 BACKGROUND

• 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.

  PMID: 14712123 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Anthony M Magit, MD

  Children's Associated Medical Group, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (5)