A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
NCT ID: NCT01253577
Last Updated: 2015-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
105 participants
INTERVENTIONAL
2009-12-31
2010-10-31
Brief Summary
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Detailed Description
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The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug Coated
Sinus stent coated with steroid
Sinus Stent with drug coating
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Non coated
Sinus stent without drug coating
Non Coated Sinus Stent
Sinus stent (visually identical) without drug coating
Interventions
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Sinus Stent with drug coating
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Non Coated Sinus Stent
Sinus stent (visually identical) without drug coating
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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 Criteria
* oral steroid dependent condition
* glaucoma, ocular hypertension, posterior subcapsular cataracts
* middle turbinate resection
18 Years
ALL
No
Sponsors
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Intersect ENT
INDUSTRY
Responsible Party
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Principal Investigators
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Bradley Marple, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Neil Bhattacharyya, MD
Role: PRINCIPAL_INVESTIGATOR
Brighan & Women's Hospital
Locations
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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
Countries
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References
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Han JK, Marple BF, Smith TL, Murr AH, Lanier BJ, Stambaugh JW, Mugglin AS. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012 Jul-Aug;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.
Other Identifiers
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P500-1009
Identifier Type: -
Identifier Source: org_study_id
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