Not yet recruiting NCT06642116
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
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.
- Who it may be relevant to
- Registry conditions: Rhinosinusitis Chronic, Wound Healing, Sinus Surgery, Mometasone Furoate. 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
- Center list to be confirmed — check the primary protocol.
- 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 →
Overview
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.
Interventions
- Device OCEAN
Biodegradable nasal dressing
Primary outcome measures
- Safety [Time frame: Up to 25 days after surgery]
- Performance [Time frame: Up to 25 days after surgery]
Eligibility criteria
Inclusion criteria
- Patient is 18 years or older
- Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
- Patient is willing and able to comply with all study elements as indicated by their written informed consent
- Patients with a pre-operative Lund-MacKay score of ≥ 6.
Exclusion criteria
- Patient is pregnant or nursing
- Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
- Patients with a platelet disorder
- Patients with a known or suspected allergy to device components
- Patients with known hemophilia
- Patients with insulin dependent diabetics
- Patients with an oral steroid dependent condition
- Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
- Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
- Patients that require nasal ointments or creams at time of device placement
- 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
- Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
- Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
- Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06642116 · CIP-4