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

A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps; Chronic Rhinosinusitis (CRS)
• Intervention / Treatment: Device: OCEAN; Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Grace Dennis-Little, PhD; Phone Number: 7062470251; Email: sgdennislittle@regenity.com
• Study Contact Backup: Name: Betty IJmker; Email: bijmker@regenity.com

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCEAN; Application after nasal/sinus surgery	Device: OCEAN; Biodegradable nasal dressing applied after sinus/nasal surgery
Active Comparator: Steroid-eluting Sinus Stent; Application after nasal/sinus surgery	Device: Steroid-eluting sinus stent; Applied after sinus/nasal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Serious Adverse Events	Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.	Up to Day 25
Endoscopic Assessment	Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.	Day 25

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse Events	Assessment of all adverse events.	Up to Day 90
Endoscopic Evaluation of Sinonasal Cavities	Endoscopic evaluation of sinonasal cavities for to evaluate wound healing.	Days 25 and 90
Rate of post-operative interventions	Rate of post-operative interventions, including surgical intervention to separate adhesions, and/or oral steroid intervention, and/or biologics.	Up to Day 25 and Day 90

Collaborators and Investigators

• Sponsor: Polyganics BV
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mometasone Furoate; Nasal Packing
• Other Study ID Numbers: CIP-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes