300
Participants
Start Date
December 31, 2014
Primary Completion Date
October 31, 2016
Study Completion Date
October 31, 2016
S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily
Sham
In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.
Madison ENT & Facial Plastic Surgery, New York
Mount Sinai Hospital, New York
Albany ENT & Allergy, Albany
Bethlehem Ear, Nose and Throat Associates, Bethlehem
University of Pennsylvania, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
GW Medical Facility Associates, Washington D.C.
Reston ENT, Reston
Johns Hopkins, Baltimore
Virginia ENT, Richmond
Eastern Virginia Medical School, Norfolk
Charlotte Eye, Ear, Nose and Throat Associates, Concord
Medical University of South Carolina, Charleston
ENT of Georgia, Atlanta
University of Miami, Miami
South Florida ENT, Miami
& Facial Plastic Surgery, Riverview
The University of Alabama Birmingham, Birmingham
Vanderbilt University, Nashville
University of Mississippi Medical Center, Jackson
Advanced ENT and Allergy, Louisville
Rontal Akervall Clinic, Royal Oak
Iowa ENT Center, West Des Moines
Medical College of Wisconsin - Greenway Clinic, Milwaukee
DuPage Medical Group, Naperville
Northwestern Medical Faculty Foundation, Department of Otolaryngology, Chicago
University of Kansas Medical Center, Kansas City
Associated Surgical Specialists, Covington
University of Oklahoma, Oklahoma City
University of Texas, Houston
Colorado ENT and Allergy, Colorado Springs
Intermountain/ENT Center of UT, Salt Lake City
University of Utah, Salt Lake City
Cache Valley ENT, North Logan
Breathe America/NM Sinus, Albuquerque
Ear, Nose and Throat Consultants of Nevada, Las Vegas
Kaiser Permanente Orange County Irvine Medical Center, Irvine
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc., Sacramento
Yale University School of Medicine, New Haven
Summit Medical Group, Berkeley Heights
Lead Sponsor
Intersect ENT
INDUSTRY