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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhinosinusitis Chronic; Wound Healing; Sinus Surgery; Mometasone Furoate
• Intervention / Treatment: Device: OCEAN

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carola Hartgers; Phone Number: 050 588 6582; Email: chartgers@regenity.com
• Study Contact Backup: Name: Betty IJmker; Phone Number: 050 588 6582; Email: bijmker@regenity.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCEAN; Application of OCEAN after nasal/sinus surgery	Device: OCEAN; Biodegradable nasal dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery	Up to 25 days after surgery
Performance	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)	Up to 25 days after surgery

Collaborators and Investigators

• Sponsor: Polyganics BV
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Rhinitis; Sinusitis; Rhinosinusitis
• Other Study ID Numbers: CIP-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No