Status:
COMPLETED
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Lead Sponsor:
Intersect ENT
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusiti...
Detailed Description
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusiti...
Eligibility Criteria
Inclusion
- Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
- Patient is indicated for and has consented to FESS.
- FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.
- CT Imaging
- CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
- Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.
Exclusion
- insulin dependent diabetics
- oral steroid dependent condition
- glaucoma, ocular hypertension, posterior subcapsular cataracts
- middle turbinate resection
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01253577
Start Date
December 1 2009
End Date
October 1 2010
Last Update
June 22 2015
Active Locations (11)
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1
Central California ENT
Fresno, California, United States, 93720
2
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80909
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Northshore University Health System
Evanston, Illinois, United States, 60201