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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Polyganics BV
Study ID
NCT07286201
Status
Enrolling By Invitation

Conditions

  • Chronic Rhinosinusitis (CRS)
  • Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OCEAN — DEVICE
    Biodegradable nasal dressing applied after sinus/nasal surgery
  • Steroid-eluting sinus stent — DEVICE
    Applied after sinus/nasal surgery

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OCEAN
    Application after nasal/sinus surgery
  • Active Comparator: Steroid-eluting Sinus Stent
    Application after nasal/sinus surgery

Primary Outcome Measure

Rate of Serious Adverse Events [ Time Frame: Up to Day 25 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Colorado ENT & AllergyColorado SpringsColorado80923-
Emory UniversityAtlantaGeorgia30308-
University of Illinois at ChicagoChicagoIllinois60612-
Louisiana State University Health at ShreveportShreveportLouisiana71103-
Centers for Advanced ENT CareTowsonMaryland21204-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Texas HealthHoustonTexas77030-
Ogden ClinicOgdenUtah84403-
ENT Allergy & AssociatesPuyallupWashington98374-

Find similar trials in Colorado Springs, CO

By research site
Colorado ENT & Allergy· Colorado Springs, COEmory University· Atlanta, GAUniversity of Illinois at Chicago· Chicago, ILLouisiana State University Health at Shreveport· Shreveport, LACenters for Advanced ENT Care· Towson, MDMedical University of South Carolina· Charleston, SC

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