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

Polyganics

Status: Not yet enrolling

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

Treatments: Device: OCEAN

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06642116

CIP-4

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

OCEAN

Experimental group

Description:

Application of OCEAN after nasal/sinus surgery

Treatment:

Device: OCEAN