Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Conditions
Keywords
Nasal Packing, Mometasone Furoate
Brief 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.
Detailed description
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
Interventions
DEVICEOCEAN
Biodegradable nasal dressing applied after sinus/nasal surgery
DEVICESteroid-eluting sinus stent
Applied after sinus/nasal surgery
Sponsors
Polyganics BV
NAMSA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Intra-patient study design comparing test-treated to control-treated cavities.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events | Up to Day 25 | Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing. |
| Endoscopic Assessment | Day 25 | Endoscopic assessment of wound healing to compare test-treated and control-treated cavities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events | Up to Day 90 | Assessment of all adverse events. |
| Endoscopic Evaluation of Sinonasal Cavities | Days 25 and 90 | Endoscopic evaluation of sinonasal cavities for to evaluate wound healing. |
| Rate of post-operative interventions | Up to Day 25 and Day 90 | Rate of post-operative interventions, including surgical intervention to separate adhesions, and/or oral steroid intervention, and/or biologics. |
Countries
United States
Outcome results
None listed