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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
2026-01
Completion Date
2027-01
Last Updated
2025-12-16
Healthy Volunteers
No
Interventions
OCEAN
Biodegradable nasal dressing applied after sinus/nasal surgery
Steroid-eluting sinus stent
Applied after sinus/nasal surgery