Polyganics BV
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.
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
Inclusion Criteria: 1. Subject is 18 years or older 2. Subject is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitus with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP) and is indicated for bilateral complete ethmoidectomy (anterior and posterior ethmoidectomy) at a minimum. Additional sinuses may be operated on at the surgeon's discretion. 3. Subject is willing and able to provide informed consent. 4. Subject is willing and able to comply with the investigational plan requirements. 5. Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril…
Biodegradable nasal dressing applied after sinus/nasal surgery
Applied after sinus/nasal surgery