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NOT YET RECRUITING
NCT07286201
NA

Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)

Sponsor: Polyganics BV

View on ClinicalTrials.gov

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

DEVICE

OCEAN

Biodegradable nasal dressing applied after sinus/nasal surgery

DEVICE

Steroid-eluting sinus stent

Applied after sinus/nasal surgery