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ENROLLING BY INVITATION
NCT07286201
NA

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

Sponsor: Polyganics BV

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-03-19

Completion Date

2027-08

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DEVICE

OCEAN

Biodegradable nasal dressing applied after sinus/nasal surgery

DEVICE

Steroid-eluting sinus stent

Applied after sinus/nasal surgery

Locations (9)

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Emory University

Atlanta, Georgia, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Louisiana State University Health at Shreveport

Shreveport, Louisiana, United States

Centers for Advanced ENT Care

Towson, Maryland, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Health

Houston, Texas, United States

Ogden Clinic

Ogden, Utah, United States

ENT Allergy & Associates

Puyallup, Washington, United States