242
Participants
Start Date
July 31, 2007
Primary Completion Date
June 30, 2011
Study Completion Date
June 30, 2011
Radiofrequency Turbinate Reduction
Radiofrequency Turbinate Reduction
Sham RF
The steps of the procedure are as follows: 1) application of topical anesthetic to the turbinate mucosa bilaterally; 2) injection of 1.0 ml of lidocaine 1% with epinephrine 1:100,000 with a 30-gauge needle into each inferior turbinate anteriorly; 3) delay five minutes for local anesthetic to take full effect; 4) re-insertion of the anesthetic needle to check for complete anesthesia on one side, and injection of another 1.0 ml of lidocaine 1% with epinephrine 1:100,000 5) placement of the radiofrequency electrode (23-gauge, 1 cm long) into the inferior turbinate; 6) delivery of 300 Joules of radiofrequency energy to the turbinate over 29 seconds (no energy will be delivered in sham procedure)7) placement of a cotton pledget (soaked in oxymetazoline solution 0.05%) against the treatment site 8) repeat steps 3 - 8 for the contra-lateral inferior turbinate; 9) removal of the cotton pledgets after several minutes; and 11) observation of hemostasis.
UW Sleep Disorders Center at Harborview Medical Center, Seattle
Virginia Mason Medical Center, Seattle
University of Washington General Clinical Research Center, Seattle
National Institutes of Health (NIH)
NIH
University of Washington
OTHER