Enrolling by invitation NCT07286201

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

No phase Interventional Chronic Rhinosinusitis (CRS) Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: OCEAN, Steroid-eluting sinus stent.
Who it may be relevant to: Registry conditions: Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

Device OCEAN
Biodegradable nasal dressing applied after sinus/nasal surgery
Device Steroid-eluting sinus stent
Applied after sinus/nasal surgery

Primary outcome measures

Rate of Serious Adverse Events [Time frame: Up to Day 25]
Endoscopic Assessment [Time frame: Day 25]

Secondary outcome measures (3)

Rate of Adverse Events [Time frame: Up to Day 90]
Endoscopic Evaluation of Sinonasal Cavities [Time frame: Days 25 and 90]
Rate of post-operative interventions [Time frame: Up to Day 25 and Day 90]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Single group
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 9 centers

Colorado ENT & Allergy — Colorado Springs
Emory University — Atlanta
University of Illinois at Chicago — Chicago
Louisiana State University Health at Shreveport — Shreveport
Centers for Advanced ENT Care — Towson
Medical University of South Carolina — Charleston
University of Texas Health — Houston
Ogden Clinic — Ogden
… and 1 more center

Identifiers

NCT: NCT07286201 · CIP-6

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗