A randomized controlled trial
This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Sinus implant with 370 mcg of mometasone furoate released over 30 days
Sacramento ENT
Sacramento, California, United States
ENT Assoicates of South Florida
Boca Raton, Florida, United States
ENT of Georgia
Atlanta, Georgia, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Patency Rate
Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.
Time frame: Day 30
Inflammation Score
Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
Time frame: Day 30
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Associated Surgical Specialists
Covington, Louisiana, United States
St. Luke's ENT Specialists
Kansas City, Missouri, United States
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, United States
Madison ENT
New York, New York, United States
Ohio Sinus Institute
Dublin, Ohio, United States