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

NCT07286201 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP-6
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps; Chronic Rhinosinusitis (CRS)

Keywords

Nasal Packing; Mometasone Furoate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of Adverse Events

  Up to Day 90

• Endoscopic Evaluation of Sinonasal Cavities

  Days 25 and 90

• Rate of post-operative interventions

  Up to Day 25 and Day 90

Study Arms (2)

OCEAN

EXPERIMENTAL

Application after nasal/sinus surgery

Device: OCEAN

Steroid-eluting Sinus Stent

ACTIVE COMPARATOR

Application after nasal/sinus surgery

Device: Steroid-eluting sinus stent

Interventions

OCEAN DEVICE

Biodegradable nasal dressing applied after sinus/nasal surgery

OCEAN

Steroid-eluting sinus stent DEVICE

Applied after sinus/nasal surgery

Steroid-eluting Sinus Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years or older
• 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.
• Subject is willing and able to provide informed consent.
• Subject is willing and able to comply with the investigational plan requirements.
• Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
• Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤ 2.
• Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study.

You may not qualify if:

• Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
• Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
• Subject with a known or suspected allergy to device components.
• Subject with known hemophilia.
• Subject with insulin dependent diabetes.
• Subject with an oral steroid dependent condition.
• Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts.
• Subject with a (previous) diagnosis of Samter's Triad (AERD).
• Subject that requires nasal ointments or creams at time of device placement.
• 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.
• Subject with plans to (or otherwise anticipate the need to) undergo an ENT procedure within the 90-day study follow-up.
• Subject participating in another clinical research study (within 30 days prior to screening up to 90 days post-operative).
• Subject that used any form of biologics within 90 days prior to sinus surgery and during follow-up to day 25.
• Subject that used any form of corticosteroid within 2 weeks prior to sinus surgery.

Sponsors & Collaborators

• Polyganics BV: lead
• NAMSA: collaborator

Central Study Contacts

Sarah Grace Dennis-Little, PhD

CONTACT

7062470251; sgdennislittle@regenity.com

Betty IJmker

CONTACT

bijmker@regenity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share