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Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
Sponsor: Polyganics BV
Summary
The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.
Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-03-19
Completion Date
2027-08
Last Updated
2026-06-25
Healthy Volunteers
No
Interventions
OCEAN
Biodegradable nasal dressing applied after sinus/nasal surgery
Steroid-eluting sinus stent
Applied after sinus/nasal surgery
Locations (9)
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Emory University
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Louisiana State University Health at Shreveport
Shreveport, Louisiana, United States
Centers for Advanced ENT Care
Towson, Maryland, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Health
Houston, Texas, United States
Ogden Clinic
Ogden, Utah, United States
ENT Allergy & Associates
Puyallup, Washington, United States