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

Launched by POLYGANICS BV · Oct 11, 2024

Keywords

ClinConnect Summary

The clinical trial is looking at a new nasal dressing called OCEAN®, which contains a medication called mometasone furoate. This study aims to see how safe and effective OCEAN® is for helping patients heal after they have surgery for chronic sinus issues. The trial will include adults aged 18 and older who are scheduled for specific types of sinus surgery. To be eligible, patients need to have a certain level of severity in their condition, as measured by a score called the Lund-MacKay score.

Participants in this trial will be monitored to see how well the nasal dressing helps with recovery following surgery. However, there are certain criteria that could exclude someone from participating, such as being pregnant, having certain medical conditions, or needing other treatments during the study. Overall, this trial is an important step in understanding how this new dressing might improve healing after sinus surgery, and it could potentially benefit many patients dealing with chronic sinus issues.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is 18 years or older
• • 2. Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
• • 3. Patient is willing and able to comply with all study elements as indicated by their written informed consent
• • 4. Patients with a pre-operative Lund-MacKay score of ≥ 6.
• Exclusion Criteria:
• • 1. Patient is pregnant or nursing
• • 2. Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
• • 3. Patients with a platelet disorder
• • 4. Patients with a known or suspected allergy to device components
• • 5. Patients with known hemophilia
• • 6. Patients with insulin dependent diabetics
• • 7. Patients with an oral steroid dependent condition
• • 8. Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
• • 9. Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
• • 10. Patients that require nasal ointments or creams at time of device placement
• • 11. Patients 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. Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
• • 13. Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
• • 14. Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.