Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone … (NCT07286201) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
United States110 participantsStarted 2026-03-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is 18 years or older
. 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.
. Subject is willing and able to provide informed consent.
. Subject is willing and able to comply with the investigational plan requirements.
. Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
. Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤ 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study.
Exclusion criteria
. Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
. Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
. Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
. Subject with a known or suspected allergy to device components.
. Subject with known hemophilia.
. Subject with insulin dependent diabetes.
. Subject with an oral steroid dependent condition.
. Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts.