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Clinical Trials in the USA / NCT07286201
Enrolling by invitation Not applicable

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

NCT07286201 · tracked via the Priya Life Science USA tracker
Sponsor
Polyganics BV
Phase
Not applicable
Started
2026-03-19
Last updated
2026-06-25

Condition(s) studied

Chronic Rhinosinusitis (CRS)Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Investigational drug(s) / intervention(s)

OCEANSteroid-eluting sinus stent

OCEAN: Biodegradable nasal dressing applied after sinus/nasal surgery

Steroid-eluting sinus stent: Applied after sinus/nasal surgery

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subject is 18 years or older 2. 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. 3. Subject is willing and able to provide informed consent. 4. Subject is willing and able to comply with the investigational plan requirements. 5. Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril). 6. Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤ 2. 7. Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study. Exclusion Criteria: 1. Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. 2. Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides). 3. Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin. 4. Subject with a known or suspected allergy to device components. 5. Subject with known hemophilia. 6. Subject with insulin dependent diabetes. 7. Subject with an oral steroid dependent condition. 8. Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts. 9. Subject with a (previous) diagnosis of Samter's Triad (AERD). 10. Subject that requires nasal ointments or creams at time of device placement. 11. Subject with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data. 12. Subject with plans to (or otherwise anticipate the need to) undergo an ENT procedure within the 90-day study follow-up. 13. Subject participating in another clinical research study (within 30 days prior to screening up to 90 days post-operative). 14. Subject that used any form of biologics within 90 days prior to sinus surgery and during follow-up to day 25. 15. Subject that used any form of corticosteroid within 2 weeks prior to sinus surgery.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Colorado ENT & Allergy Colorado Springs Colorado
Emory University Atlanta Georgia
University of Illinois at Chicago Chicago Illinois
Louisiana State University Health at Shreveport Shreveport Louisiana
Centers for Advanced ENT Care Towson Maryland
Medical University of South Carolina Charleston South Carolina
University of Texas Health Houston Texas
Ogden Clinic Ogden Utah
ENT Allergy & Associates Puyallup Washington

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286201 on ClinicalTrials.gov ↗ ← All trials in the USA