Safety and Performance of OCEAN Nasal Dressing for Chronic Rhinosinusitis
This study is evaluating a new bioresorbable (dissolvable) nasal dressing called OCEAN, which contains mometasone furoate (a steroid). It's designed for people undergoing sinus surgery for chronic rhinosinusitis (ongoing inflammation of the sinuses), with or without nasal polyps. Researchers want to see if OCEAN is safe and helps with healing after surgery, and if it works as well as a standard steroid-eluting (steroid-releasing) sinus stent. You could be eligible if you are 18 or older and scheduled for bilateral endoscopic sinus surgery. The study aims to enroll 110 participants and is currently recruiting.
- Study design
- This is a multicenter, randomized, single-blinded study comparing OCEAN to a steroid-eluting sinus stent in 110 participants across up to 13 sites in the United States.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 25 days to assess serious adverse events and endoscopic healing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
At a glance
Conditions
Where it's being run
9 sites across 9 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Rate of Serious Adverse EventsUp to Day 25
Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
- Endoscopic AssessmentDay 25
Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.