120
Participants
Start Date
June 1, 2021
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
Balloon sinuplasty of maxillary sinuses
A shapeable tip of the balloon dilatation device (Entellus XprESS LoProfile; Stryker Corporation, Kalamazoo, Michigan, U.S.A.), with maxillary bending, is inserted into the maxillary sinus ostium. Then guided with the tip, a flexible balloon (6 mm x 20 mm) is gently inserted into the ostium and inflated up to 12 atm for 15 seconds. The dilatation is repeated one more time. The same procedure is performed for both maxillary sinuses.
Sham surgery
"The middle meatus is gently palpated with a curved suction tip (the tip is not connected to a suction unit). The curved suction tip is placed medial to the uncinate process. In order to create a better placebo effect, the operating doctor says: Now inflate the balloon up to 12 atm for 15 seconds. After 15 seconds the doctor says: Deflate the balloon. This is repeated one more time. Similar procedure is carried out on both sides."
RECRUITING
Tampere University Hospital, Tampere
Tampere University Hospital
OTHER