100
Participants
Start Date
January 31, 2013
Primary Completion Date
November 30, 2013
Study Completion Date
May 31, 2014
S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Sham procedure
In-office bilateral sham procedure
Mometasone furoate nasal spray
Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90
ENT and Allergy Associates, Lake Success
Albany ENT & Allergy Services, Albany
Bethlehem ENT Specialty Physicians Associates, Bethlehem
University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery, Philadelphia
Eastern Virginia Medical School Department of Otolaryngology, Norfolk
Piedmont Ear, Nose & Throat Associates, Winston-Salem
Medical University of South Carolina, Charleston
ENT of Georgia, Atlanta
South Florida ENT Associates, Miami
Advanced ENT & Allergy, Louisville
Medical College of Wisconsin, Milwaukee
Northwestern University, Department of Otolaryngology-Head & Neck Surgery, Chicago
Colorado Ear, Nose, Throat & Allergy, Colorado Springs
Intermountain Ear, Nose & Throat Center, Salt Lake City
Cedars-Sinai Medical Center, Sinus Center of Excellence, Los Angeles
California Sinus Centers, Atherton
Sacramento Ear, Nose and Throat, Sacramento
Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery, Portland
Summit Medical Group, Berkeley Heights
Lead Sponsor
Intersect ENT
INDUSTRY