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.

NCT07286201

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Polyganics BV
~110 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:OCEANSteroid-eluting sinus stent

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Serious Adverse Events
Measured over Up to Day 25
+1 more outcome measured
Chronic Rhinosinusitis (CRS)
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
9 sites across 9 states
Colorado1
Georgia1
Illinois1
Louisiana1
Maryland1
South Carolina1
Texas1
Utah1

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • 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.