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NCT Number: NCT06642116

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OCEAN

Device

Biodegradable nasal dressing

Primary outcomes

  1. Safety

    Time frame: Up to 25 days after surgery

    Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery

  2. Performance

    Time frame: Up to 25 days after surgery

    Endoscopic evaluation of aspects of wound healing as assessed using the Lund-Kennedy Endoscopic Score System (LKS).

    The LKS assesses various factors like edema, crusting, discharge, polyps, and mucosal inflammation. Each parameter is scored from 0 to 2, with 0 being normal and 2 representing severe findings. Higher scores on the Lund-Kennedy Scale indicate a worse outcome, reflecting more severe disease or poor wound healing.

    Minimum Value: 0 (This represents no signs of inflammation or disease); Maximum Value: 20 (This indicates the most severe signs of disease or inflammation)

Study contacts

Contact information is provided by the study sponsor or research team.

Betty IJmker

CONTACT

[email protected]

050 588 6582

Carola Hartgers

CONTACT

[email protected]

050 588 6582

Sponsors and collaborators

Lead sponsor

Polyganics BV

Industry

Collaborators

  • NAMSA

Registry information

Acronym: ENHANCE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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