Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

October 31, 2016

Conditions
Chronic Sinusitis
Interventions
DEVICE

PROPEL Mini Sinus Implant.

Placement of sinus implant following frontal sinus surgery

PROCEDURE

Sinus Surgery alone

Sinus surgery only, without implant placement

DEVICE

Propel Nova Sinus Implant

Placement of sinus implant following frontal sinus surgery

Trial Locations (10)

12206

Albany ENT and Allergy, Albany

20006

George Washington University Medical Faculty Associates, Washington D.C.

23507

East Virginia Medical School, Norfolk

30342

ENT of Georgia, Atlanta

40207

Advanced ENT and Allergy, Louisville

77030

University of Texas Health Science Center at Houston, Houston

90503

Breathe Clear Institute of Sinus and Allergy Relief, Torrance

95815

Sacramento Ear, Nose and Throat, Sacramento

97239

Oregon Health and Science University, Portland

06851

The Connecticut Center for Advanced ENT Care, Norwalk

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Advance Research Associates

OTHER

lead

Intersect ENT

INDUSTRY