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A dissolvable dressing that leaches steroid into healing sinuses

NCT ID NCT06642116

Symptom relief Sponsor: Polyganics BV Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a biodegradable nasal dressing called OCEAN that releases the steroid mometasone furoate. The dressing is placed in the nose after endoscopic sinus surgery in adults with chronic rhinosinusitis, with or without nasal polyps. The trial checks safety by counting serious side effects and checks healing by scoring the inside of the nose for swelling, crusting, and discharge. About 10 patients take part, and everyone receives the dressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A dissolvable nasal dressing that releases the steroid mometasone furoate
What this could lead to
If it works, surgeons could place this dressing during sinus surgery to calm inflammation and help the lining heal without a separate daily steroid routine.
What could go wrong
This is a very small, early study of 10 people with no comparison group, so it cannot prove the dressing works better than standard care. The dressing could cause irritation, bleeding, or infection, and results may not apply to all sinus surgery patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Feb 2025

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mometasone furoate Rhinosinusitis chronic Sinus surgery Wound healing

Contacts and locations

Locations

  • Centers for Advanced ENT Care (CAdENT)

    Baltimore, Maryland, 21204, United States

  • Ear Nose and Throat Consultants

    Detroit, Michigan, 48034, United States

  • Ogden Clinic

    Ogden, Utah, 84403, United States

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