S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Chronic SinusitisNasal Polyposis
Interventions
DRUG

S8 Sinus Implant

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

DRUG

Mometasone furoate nasal spray

Mometasone furoate nasal spray (200mcg) once daily

PROCEDURE

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.

Trial Locations (40)

10016

Madison ENT & Facial Plastic Surgery, New York

10029

Mount Sinai Hospital, New York

12206

Albany ENT & Allergy, Albany

18017

Bethlehem Ear, Nose and Throat Associates, Bethlehem

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

20037

GW Medical Facility Associates, Washington D.C.

20190

Reston ENT, Reston

21287

Johns Hopkins, Baltimore

23233

Virginia ENT, Richmond

23507

Eastern Virginia Medical School, Norfolk

29025

Charlotte Eye, Ear, Nose and Throat Associates, Concord

29425

Medical University of South Carolina, Charleston

30342

ENT of Georgia, Atlanta

33136

University of Miami, Miami

33176

South Florida ENT, Miami

33578

& Facial Plastic Surgery, Riverview

35233

The University of Alabama Birmingham, Birmingham

37232

Vanderbilt University, Nashville

39216

University of Mississippi Medical Center, Jackson

40207

Advanced ENT and Allergy, Louisville

48073

Rontal Akervall Clinic, Royal Oak

50265

Iowa ENT Center, West Des Moines

53227

Medical College of Wisconsin - Greenway Clinic, Milwaukee

60540

DuPage Medical Group, Naperville

60611

Northwestern Medical Faculty Foundation, Department of Otolaryngology, Chicago

66160

University of Kansas Medical Center, Kansas City

70433

Associated Surgical Specialists, Covington

73104

University of Oklahoma, Oklahoma City

77030

University of Texas, Houston

80909

Colorado ENT and Allergy, Colorado Springs

84102

Intermountain/ENT Center of UT, Salt Lake City

84132

University of Utah, Salt Lake City

84341

Cache Valley ENT, North Logan

87109

Breathe America/NM Sinus, Albuquerque

89128

Ear, Nose and Throat Consultants of Nevada, Las Vegas

92618

Kaiser Permanente Orange County Irvine Medical Center, Irvine

95815

Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc., Sacramento

06519

Yale University School of Medicine, New Haven

07922

Summit Medical Group, Berkeley Heights

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Intersect ENT

INDUSTRY