Not Yet RecruitingNot Applicable

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

110 participantsStarted 2026-01

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 range18 Years

SexALL

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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.
✓. 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.

What they're measuring

Rate of Serious Adverse Events

Timeframe: Up to Day 25

Endoscopic Assessment

Timeframe: Day 25

Trial details

NCT IDNCT07286201

SponsorPolyganics BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Sarah Grace Dennis-Little, PhD

7062470251 sgdennislittle@regenity.com

View on ClinicalTrials.gov More Chronic Rhinosinusitis (CRS) trials