Bioresorbable Nasal Dressing for Sinusitis
(ENHANCE II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with chronic sinusitis who are scheduled for sinus surgery on both sides of the nose. Participants must not be pregnant, must agree to avoid pregnancy during the study, and need to be able to follow study instructions and give consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- OCEAN
- Steroid-eluting sinus stent
Trial Overview
The study compares a new bioresorbable nasal dressing called OCEAN with an existing steroid-releasing sinus stent. Both are used after sinus surgery to help healing. The goal is to see if OCEAN works as well and is as safe as the current standard.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Application after nasal/sinus surgery
Application after nasal/sinus surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Polyganics BV
Lead Sponsor
NAMSA
Collaborator
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