Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Completed · Phase 4

Conditions studied: Ethmoid Sinusitis, Rhinosinusitis

In brief

The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.

Key facts

Study ID

NCT00554190

Run by

Carbylan Therapeutics, Inc.

People needed

29

Starts

2007-05-01

Expected to finish

2007-12-01

Last updated by the study team

2009-04-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who:
• Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
• Have bilateral ethmoid sinus disease
• Are scheduled for bilateral anterior or total ethmoidectomy

You may not qualify if…

• Unilateral ethmoid sinus disease
• Partial resection of middle turbinates, unilateral or bilateral

Where it is running

• Alabama Nasal & Sinus Center — Birmingham, Alabama, United States
• University of California, San Francisco, Dept of Otolaryngology — San Francisco, California, United States
• Northwestern University Medical Center, Department of Otolaryngology — Chicago, Illinois, United States
• Cleveland Nasal Sinus & Sleep — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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