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 (ENHANCE II)

NCT07286201 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Polyganics BV
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	110
Start date	2026-01
Completion	2027-01

Conditions

• Chronic Rhinosinusitis (CRS)
• Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

• OCEAN
• Steroid-eluting sinus stent

Primary outcomes

• Rate of Serious Adverse Events — Up to Day 25
  Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
• Endoscopic Assessment — Day 25
  Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.