A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Completed · Phase 3

Conditions studied: Chronic Sinusitis

In brief

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 Sinusitis (CS).

Key facts

Study ID

NCT01253577

Run by

Intersect ENT

People needed

105

Starts

2009-12-01

Expected to finish

2010-10-01

Last updated by the study team

2015-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Inclusion Criteria:
• 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.

You may not qualify if…

• insulin dependent diabetics
• oral steroid dependent condition
• glaucoma, ocular hypertension, posterior subcapsular cataracts
• middle turbinate resection

Where it is running

• Central California ENT — Fresno, California, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Northshore University Health System — Evanston, Illinois, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Charlotte Eye, ENT Associates — Charlotte, North Carolina, United States
• Austin ENT Clinics — Austin, Texas, United States
• University of Texas SW Medical School — Dallas, Texas, United States
• University of Texas Medical School — Houston, Texas, United States
• Intermountain ENT — Salt Lake City, Utah, United States
• Eastern Virgina Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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