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

Not Applicable

Not yet recruiting

• Conditions: Rhinosinusitis Chronic; Wound Healing; Sinus Surgery; Mometasone Furoate

• Registration Number: NCT06642116
• Lead Sponsor: Polyganics BV

Brief Summary

The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Study Start: 2024-11
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety	Up to 25 days after surgery	Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery
Performance	Up to 25 days after surgery	Endoscopic evaluation of aspects of wound healing as assessed using the Lund-Kennedy Endoscopic Score System (LKS).; The LKS assesses various factors like edema, crusting, discharge, polyps, and mucosal inflammation. Each parameter is scored from 0 to 2, with 0 being normal and 2 representing severe findings. Higher scores on the Lund-Kennedy Scale indicate a worse outcome, reflecting more severe disease or poor wound healing.; Minimum Value: 0 (This represents no signs of inflammation or disease); Maximum Value: 20 (This indicates the most severe signs of disease or inflammation)