Surgical Reduction of the Inferior Turbinates for Nasal Obstruction (NCT00737906) | Clinical Trial Compass
TerminatedPhase 4
Surgical Reduction of the Inferior Turbinates for Nasal Obstruction
United States30 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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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 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.
What they're measuring
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.