Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

Stopped early · Phase 4

Conditions studied: Chronic Rhinitis, Inflammation of the Nasal Mucosa, Inflammation of Nasal Tissue

In brief

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.

Key facts

Study ID

NCT00737906

Run by

ArthroCare Corporation

People needed

30

Starts

2007-10-01

Expected to finish

2012-10-01

Last updated by the study team

2015-08-26

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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