Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPolyganics BV
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- OCEAN
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Polyganics BV
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov