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

Polyganics

Status: Not yet enrolling

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

Treatments: Device: Steroid-eluting sinus stent; Device: OCEAN

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07286201

CIP-6

Details and patient eligibility

About

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.

Full description

A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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110 participants in 2 patient groups

OCEAN

Experimental group

Description:

Application after nasal/sinus surgery

Treatment:

Device: OCEAN

Steroid-eluting Sinus Stent

Active Comparator group

Description:

Application after nasal/sinus surgery

Treatment:

Device: Steroid-eluting sinus stent